Method of fitting a prosthetic interface system using compliant members

ABSTRACT

A prosthetic or orthotic device using at least one of measurements of residual limb length or circumference to define a prosthetic socket assembly configuration, comprising modular socket components fitted to the individual user&#39;s residual limb having a mounting point for an attachment, at least one compliant member attached to at least one stabilizing unit, and at least one second compliant member attached to at least one stabilizing unit wherein the first compliant member and the second compliant member work in cooperation with the stabilizing unit(s) to control bone position and support the limb within the interface.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/886,419, filed on Feb. 1, 2018, currently pending, whichclaims priority to U.S. Provisional Patent Application Ser. No.62/499,709 filed Feb. 2, 2017, and which said U.S. patent applicationSer. No. 15/886,419 is also a continuation-in-part of U.S. patentapplication Ser. No. 15/436,961 filed Feb. 20, 2017, currently pending,which is a continuation of U.S. patent application Ser. No. 15/260,936,filed Sep. 7, 2016, now abandoned, which is a continuation-in-part ofU.S. patent application Ser. No. 14/708,274, filed May 10, 2015, nowabandoned, which claims priority to U.S. Provisional Patent ApplicationSer. No. 61/998,569 filed Jul. 1, 2014. Each of the applications listedabove is expressly incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to a limb prosthesis or orthosisfor amputees or orthotic users. More particularly, the present inventionis a new and improved method for fitting a prosthetic socket or orthoticapparatus and system utilizing simple limb measurements to yield adefined assembly and fitting configuration.

2. Background of the Invention

It is estimated that by the year 2050, the number of amputees willdouble to over 3.6 Million. American population health concerns arestrongly correlated to the weight and age of the individual. TheAmerican population and its health patterns show an increase in allhigh-risk areas as related to dysvascular disease, a leading cause ofboth stroke and amputation. In the United States, 97% of dysvascularrelated amputations involve the lower limb.

The aging baby-boomer population is just entering the age where vascularinsufficiencies tend to drastically increase, thus, a large influx ofstroke patients and amputee patients will be entering the U.S. marketalone in the coming few years.

Likewise, there exists over 30,000,000 amputees in developing nations,where less than 5% will have access to well-fitting prosthetics in theirlifetime. Three main causes of such a dramatically underserved amputeepopulation in developing nations are A. conventional prosthetics arerelatively expensive to fabricate and fit, B. there is a lack ofexpensive equipment needed to fabricate conventional prosthetics, and C.there is a lack of trained and skilled practitioners who are able to fitthem.

The prosthetics market has advanced significantly in recent years—nowutilizing many new advanced components such as computer controlled kneesand feet. However, the socket interfaces are minimally different fromwhat was being used 20 to 30 years ago. In fact, many of the socketinterfaces that are still considered state-of-the-art were originallydeveloped between the 1960's and 1990's, with only minor advancements inmaterials and suspension methods since then. The core socket interfacedesigns have gone largely unchanged.

There are numerous prosthetic and orthotic companies that providecomponents for conventional interface designs—ranging from variousembodiments of gel liners and suspension aids for prosthetics users. Ineach of these, the core interface approaches used are antiquated and indesperate need of more advanced methods of how to fit prostheticdevices.

The current state-of-the-art fails to truly accommodate for limb volumechanges, has narrow transitions from high force to no force resulting inrubbing and discomfort, and creates a volatile skin environment that ishot and sweaty.

Conventional transfemoral socket shapes hydrostatically compress theresidual limb and its tissues into a tight-fitting pre-determined bucketshape, often referred to as a “socket”. The lineage of transfemoraldesign typically include compressing the soft tissue around theunderlying muscle-channels and locking around the tuberosity/ramus invarious orientations. Conventional socket shapes remain static in sizeand shape. As the human limb changes in shape and volume, the “key in akeyhole” fit is lost.

The tight fitting nature of conventional interfaces leads to rubbing atthe trim lines. At this level the tissue compression goes from highforce to no force over a narrow band, resulting in shear forces on thefragile tissue. The use of rigid or semi-rigid materials in conventionalsocket interfaces compounds this problem. There is a need for softer,more dynamic materials to be used at transition areas, allowing forcompliant transition zones.

The hostile interface environment of conventional prosthetics is hot,full of constant perspiration, lack breathability, and are heavy. Assuch, many users suffer from various skin conditions including: skinbreakdown, pressure sores, heat rash, abrasions, chaffing, dryness,folliculitis, dermatitis, ulcers, eczema, psoriasis, and dry skin.Prosthetics users are desperately searching for better solutions to themany outstanding problems associated with conventional socketinterfaces.

The socket interface is by far the most important component of asuccessful prosthetic or orthotic device. While advanced computercontrolled joints are incredibly beneficial for enhancing functionalperformance, if the socket interface is not stable and comfortable, thehigh-tech components have little advantage.

Orthotics and prosthetics users are desperately searching for bettersolutions to the many outstanding problems associated with conventionalsocket interfaces. Much of the work in advancing the socket comfort hasbeen focused around new materials and suspension capabilities of gelliners, and lighter weight carbon fiber materials. However, the inherentsocket interface designs themselves have seen very little change in howthey are fit to the patient.

For prosthetics users, the gel liners are a soft padding that residesbetween the users' limb and the hard socket interface. While these doprovide more cushion, they do not address volume change issues, and tendto be very hot, full of perspiration, and make for a hostile environmentfor the skin. The application of a more advanced compliant-based socketinterface approach will greatly enhance the functionality and the dailyliving for the end user.

Weight Reduction

Prosthetics devices are a significant weight hanging off the body. TheCompliant Force Distribution socket interface designs, as disclosedherein, may use compliant materials within its surface area, versusthermoplastic and carbon fiber rigid encapsulated sockets, which areinherently heavier. Thus the compliant-based socket design may offer areduction in weight of over 50%.

Keeping the actual weight of prosthetic devices as low as possible iscritically important for the efficiency and comfort of the user, butjust as important is the perceived weight. The more intrinsic bonemotion within the residual limb due to soft tissue pliability in aconventional hydrostatic socket fit results in a significant loss ofbiomechanical efficiency, and an increase in the perceived weight of thedevice.

The dynamic Compliant Force Distribution socket interface designsprovide for an inherently greater biomechanical lock around theunderlying bony structure, providing for a greater one to oneconnectivity between the user's body and the device-further decreasingperceived weight.

Point Pressures and Force Distribution

One of the main areas causing abrasions within a conventional prostheticor orthotic socket interface is the trim lines. The trim lines are wherethere is a rapid transition from high pressure to no pressure. Becausethe conventional socket interface does not change in shape with thedynamic underlying body, the user's skin often rubs at the trim lines,causing abrasions. Conventionally used padded straps for instance arearound 1″-2″ wide and are typically pulled tight to provide forstability. The skin under the straps is highly compressed, and the skinjust outside of the straps is not. This narrow area of high force to noforce creates a shear point. The same issue is found at trim lines ofthe socket.

The compliant socket designs however eliminate the conventionaltrim-line transitions, and are replaced with a broad compliant fabric,allowing for a significantly broader distribution of pressures, and avery gradual transition from high forces to no forces.

No matter how much “padding” is used with conventional straps ortrimlines, the forces remain distributed within a small surface area.Compliant Force Distribution provides a more gradual transition offorces at the edges, and equalizes the amount of force per square inchwithin the load bearing areas.

Sensor Integration

The Compliant Force Distribution socket interface technology has beensuccessfully applied to high-level upper extremity amputees. Inconventional upper extremity socket designs, the electrodes tend to gapaway from the body, as they would typically be integrated into a rigidor semi-rigid socket over a dynamic body. Compliant Force Distributioninterface techniques instead maintain consistent electrode contact, asthe sensors are “hammocked” directly to the user's limbs, with no lossof connection.

The future of socket designs for other levels of amputation, as well asfor some orthotics users will incorporate various sensors, includingmyoelectric electrodes. Other than the Compliant Force DistributionTechnology, there is not an elegant method of incorporating sensors andwires within a socket interface environment. These designs solve theoutstanding issues that prevent the practical use of sensors andelectrodes within the socket, as they are akin to a hammock andinherently hold the interface tightly against the users'limb-maintaining consistent contact.

Skin Environment

Conventional interface designs encompass the user's limb, creating ahot, moist environment that leads to a variety of skin issues includingpressure sores, heat rash, abrasions, chaffing, dryness, folliculitis,dermatitis, ulcers, eczema, psoriasis, dryness, and skin breakdown.

The human skin is designed to breath. By design, the human skinperspires to cool itself, but instead, any perspiration within aconventional socket is trapped and a prosthetics user for instancetypically can pour sweat out of their socket upon taking it off.

The Compliant Force Distribution interface designs however may bebreathable, and allow for perspiration to escape, and the limb to remaincool, naturally.

Control and Stability

In transfemoral amputations for instance, the cut femur bone is nolonger directly connected to the remaining leg. With a conventionalhydrostatic socket design, the cut femur bone moves back and forthwithin the soft tissue of the residual limb, decreasing ambulationefficiency.

Randy Alley recently created the Hi-Fidelity socket to better lock theresidual bone in a consistent position within the socket (Pat. No.8,323,353). His work with the Hi-Fi demonstrates the ability to alterthe biomechanical synchronization between the residual bone andprosthesis by changing how the socket interface is fit to the user.

Likewise, the Compliant Force Distribution design is able to replicatethe lost biomechanical and neuromuscular connection between the limb andthe user by better controlling underlying bone position within thesocket, though through a radically different method. Just asimportantly, it does so in a modular, breathable way that alsoaccommodates for volume changes. Unlike Randy Alley's socket design,this approach captures the underlying bony structure in a much lessaggressive and more compliant manner, making it easier to achieve morecomfort. Instead of using aggressive compression zones that encircle thelimb, this design more elegantly captures the contouring of theunderlying anatomy to lock the bony structure in a desired orientationwith respect to the prosthesis.

By more elegantly spreading the load over a broad surface area, ourtechnology is not only reducing the amount of force per square inch, butmore importantly, is providing a much more secure connectivity betweenthe user and the device. A prosthetic or orthotic device is a mechanicalor electro-mechanical extension from the body. Every amputee forinstance gains what is called external physiological proprioception.This means that they are able to at least partially gain aproprioceptive sense of where the prosthesis is in space, in relation totheir body. When they move their leg forward to take a step, they have asense of where their leg position is in space, even though theirprosthesis is not neurally connected to their brain. However, the more“wiggle room” there is between their residual limb skeletal system andthe prosthesis, the less specificity they have of a true proprioceptivesense of their leg position.

For transfemoral amputees for instance, the femur bone section is cut atthe amputation level and is no longer directly connected to theremaining leg. With a conventional hydrostatic socket design, when thetransfemoral amputee kicks their leg forward to initiate the swing phaseof gait, their femur bone moves back and forth within the soft tissue oftheir residual limb, and they lose much of the true proprioceptive senseof leg position.

Volume Accommodating—Dynamic vs. Static

The human body is dynamic—yet the socket interfaces we use today arelargely relatively static in their size and shape. Socket interfacestypically use a rigid or semi-rigid carbon fiber shell surrounding asemi-flexible thermoplastic inner layer. While this inner layer has someflexibility, it's size and shape remain static, and cannot accommodateweight gain or loss. This leads to discomfort and degradation infunctional performance of the user if their body changes in size andshape, and no longer perfectly matches the socket interface. Just asmall body weight change of 5 lbs. can significantly affect the socketinterface fit. It is like wearing a shoe that is a couple sizes too bigor too small—except that the effect is greatly compounded, as the limbsare not designed to bear the incredible ambulation forces, as the footis designed to do.

The human body gains and loses volume due to hydration levels, foods weeat (for instance salty foods versus non-salty foods), exercise or lackthereof, eating habits, age related issues, and other diseases likediabetes and dysvascular disease.

If the socket does not perfectly fit, it leads to abrasions, rubbing,pressure on the cut end of the amputated bones, unwanted pressure onsensitive nerves, and overall discomfort. Most amputees and orthoticsusers experience socket interface discomfort from time to time. Socketinterfaces tend to need to be replaced every 1 to 3 years due to bodysize and shape changes.

The Compliant Force Distribution technology inherently accommodates forsize and shape changes in the user. These socket interface designs arecompliant-based, versus a rigid or semi-rigid shape, therefore thesocket interface can be quickly and easily user-adjusted in itstightness to provide a comfortable fit independent of weight gain orloss. As has been found with the Shoulder Disarticulation version of theCompliant Force Distribution socket interface design, the amputee isable to quickly and easily adjust the fit of their prosthetic device toensure the most comfortable fit.

Conventional prosthetic socket designs could be more closely compared towooden clog shoes, in that their size and shape do not adequatelyaccommodate for the dynamic nature of the human body. Even if the woodenclog were to be perfectly contoured to the user's foot, its comfortwould be limited, especially when the size and shape of the dynamic footwere to change. A compliant-based socket design would more closelyresemble the VIBRAM five-fingered shoes, in that they are made of a softdynamic material that perfectly contours to the user's foot, versus thefoot matching to the shoe.

Fitting Method.

Conventional socket fitting methods typically require capturing animpression of the limb shape, modifying that impression shape, anditerating through test sockets before a final fitting shape is definedand completed. Capturing the impression shape is largely accomplished byhand casting, or scanning. The cast is then either by hand orelectronically modified in shape to achieve a positive model of thesocket shape, to then pull a thermoplastic inner socket over be used indiagnostic evaluation of the fitting on the actual limb. This process istime consuming, inexact, and inefficient.

3. Description of the Known Prior Art

Conventionally used prosthetic interfaces remain as an anatomicallycontoured socket in which the residual limb fits within. This socket maybe specifically tailored to the residual limb's size and shape, but itlargely remains as a static size and shape. While some flexiblematerials may be incorporated, their flexibility is typically no morethan minor amounts of give at their edges, and not true accommodationfor the dynamic nature of the underlying body in which they are fit.

In recent years there have been a few attempts at improving lowerextremity socket interface design, and overcome some of the outstandingissues surrounding them.

One such attempt developed by Randy Alley through the Hi-Fidelity(Hi-Fi) Interface (Pat. No. 8,323,353) design offers excellent lockingaround the underlying skeletal system, versus solely hydrostatic tissueloading as with conventional designs. However, the Hi-Fi systemcurrently requires full customization for each user, and currently doesnot accommodate volume changes of the user any more so than otherconventional transfemoral designs. It also uses an enclosed socketcavity in which the limb is fit, which does not fully address theenvironmental issues of limb encapsulation. While this design could intheory be transitioned to more of a modular approach, its design bynature would still require significant customization of the variouscomponents to fit appropriately to the user.

The Alley design requires a common distal connection point for each ofthe four vertical struts. The common distal connection point holds thevertical struts in a certain orientation about the limb for atransfemoral amputee, resulting in a locked-in socket shape. While thedistal common connection point could become modular, once fit to theuser, the position of the vertical struts is maintained in a consistentposition, and is not quickly or easily adjustable for the patient.

It is important to offer a prosthetic interface design that is modularlyadjustable by the end user, in real-time, so that they can match thesocket to their limb, versus their limb having to match to the socket.In the Alley design, plastic shims may be used to adjust the staticsocket shape to the user, by placing them in between the static socketshape and the user's limb to take up space. In this invention however,our design can be modularly adjusted on the fly, allowing an end user toquickly and easily tighten or loosen to socket fit to match theirdesired comfort.

The Alley design uses struts that extend from the common distalconnection point to the proximal brim of the socket. Our design insteaduses floating force distribution anchors, to capture the long bone andconform it to the medial wall of the interface design. By using afloating design, the socket interface fully matches to the shape andsize of the underlying limb with real-time adjustability, versusrequiring a limb to match the shape of a customized socket fit to thepatient, as in the Alley design.

Additionally, the Alley design uses the vertical struts as thestructural element of the socket, and does not include any compliantmembers in the design. In our design we instead make the forcedistribution anchors as floating, and not connected as a verticalstructural element of the socket, in order to be compliant to match thecompliant body, and then can integrated flexible fabric or flexiblematerials or adjustable connectors to span as the connectors. By doingsuch, this design can effectively leverage the long bone of the limb tobecome a structural element of the socket, versus solely relying on thecarbon fiber struts to be the structural part of the design. Since thisdesign captures the long bone with floating force distribution anchors,and manages the bone position to the stabilizing anchor, the long boneis controlled and its lock within the system assists in creating astructural element of system support.

The Alley design locks the long bone in a set position from all sides,as the vertical struts compress into the soft tissue circumferentiallyaround the limb. This design instead pulls the long bone over to thestabilizing anchor, generating a more appropriate and controlled femoralangle.

According to the Alley patent, their design uses a limb encapsulatedstrut design where the struts are “appropriately contoured to apatient's residual limb” and “contains windows through which soft tissuecan flow”. Our design instead is able to use force distribution anchorsthat can either be of an off-the-shelf shape, or can be dynamic innature, not fully maintaining any particular shape, but rather match tothe shape of the limb. In addition, our design does not have windowswhich the soft tissue can flow, but rather has un-encapsulated areaswhere there is not structure, and hence no windows.

Still further, Alley's design requires areas of specific isolatedcompression zones, whereas our disclosure provides broader areas oftissue stabilization, spreading the forces across more surface area thanjust isolated struts, and instead may utilize a combination of strutsand compliant materials together to broaden the load bearing areas. InAlley's design, tissue is compressed such that the bone is locked in aposition from all sides, due to the isolated tissue compression. Ourdesign rather uses purposeful contouring around the bone such that abroader area of the limb is captured and controlled, and pulled towardthe main anchor stabilizer along the medial aspect of the interface.Alley's design further calls for areas of the interface to be “enclosedor completely open provided there is minimal restriction to soft tissueflow”. Our design instead benefits from open areas where the soft tissuemay be further controlled with compliant means, versus just relying onit to flow freely with minimal restriction.

Even further, Alley's patent calls for no less than 3 compressionportions, while our approach utilizes just 2 pseudo-compressionportions, where compliant means may be spanned in between. Our mainanchor stabilizer may be sufficient in dimensions to not necessarilycause its own tissue compression in the same manner as other narrowerstruts would, as in Alley's design.

Still further, Alley's patent also calls for the struts to be of similarlength as the long bone. In our design, the length may be modularlyadjustable, and does not necessarily need to extend to the furthestdistal end, or furthest proximal end, as our force distributionstabilizers are not directly connected to a common distal mounting pointor proximal brim as in Alley's designs.

More recently Hurley's (LIM Innovations) (patent application number2014/0135946 A1) introduced a modular version of Alley's Hi-Fi socket.Hurley's design accomplishes much the same as what was described byAlley, and functionally is equivalent how it fits to a residual limb,with the exception of being modular. Similar to Alley's design, theHurley design requires significant customization, and a complex and timeconsuming fabrication and assembly process, and encapsulates the limb ina structure that surrounds the limb as a solid structural unit. WhileHurley's design is modular in nature, the modularity of the design issuited well for a practitioner to modify it to a patient, but is notconducive for a patient to modify it on the fly in real-time. Hurley'sdesign as well locks the long bone in a set position from all sides, asthe vertical struts compress into the soft tissue circumferentiallyaround the limb. The Hurley design shares most of the same disadvantagesas Alley's design, as was discussed above, as they effectively have thesame functions in how they fit about the underlying limb.

The recent REVOLIMB design uses an adjustable Boa lacing system toslightly tighten or loosen various pads within the socket. This providesa step toward making a more accommodating socket though it still remainsas a fully encapsulated limb environment, is complex to fabricate,requires significant customization, and is limited in its volumeaccommodation.

Cornell (Pat. No. 8,945,237) disclosed a transfemoral socket using afabric spanned across one side of the frame, referred to as a sail. Hisdisclosure spans the limb circumferentially, but fails to capture ormanage the long bone. In his sail design, the limb is simplyencapsulated with a combination of rigid frame, and flexible fabric,though the entire limb is encapsulated circumferentially giving asimilar socket shape and effects as conventional socket designs. Themain advantage that his sail material is that it provides moreflexibility in sitting, and is adjustable. However, by not controllingthe bone position within the socket, it fails to influence thebiomechanical efficiencies while walking.

Meanwhile, Cornell's disclosure also calls for the remainder of the limbwhich is not supported by the rigid support to be supported by thefabric sail support, to create a hydrostatic weight bearing support ofthe entire limb and its tissue. Conversely, in our disclosure, we maypurposely maintain open areas to allow the tissue to expand out asneeded, so that we can compress the medial/lateral dimension, drawingthe long bone into proximity with the anchor stabilizer.

The notion of using a rigid J-shaped support, as Cornell discloses, hasbeen used in the prosthetics field for many years. Between 1999 and 2006various tests were conducted at Sabolich Prosthetics to cut down theframe's trimlines to more a micro-frame design, resembling the Hi-Fisocket in look, though not necessarily fully in function with aggressivecompression zones in the same way as Alley has demonstrated. Theseclinical fitting experiments, as well as the Hi-Fi sockets design, havedemonstrated that the force coupling within a transfemoral socket can beachieved through a micro-frame structure, versus a fully encapsulatedframe. Various tests were conducted using a J-shaped main frame, with acompliant silicon material encircling the limb that would be connectedto the J-shaped frame. We found that the limb was able to remain stablein such a setup. Distal cups trimmed out at the distal end of thesocket, and J shaped trimlines have been common in various socket shapesfor many years (Schuch, Michael, Transfemoral Amputation: ProstheticManagement, Atlas of Limb Prosthetics 20B).

Other prosthetic component manufacturers provide components, such as gelliners, for use in conventional sockets, which do not significantlydepart from conventional socket design. The Ossur Seal-In V liner forinstance is a flexible thermoplastic/silicon sock that rolls over theamputee's residual limb, which then fits into the conventional socket.The sealing rings of this design offer a better method of suspending theprosthesis than predecessor designs, by forming a suction sealing effecttoward the distal end of the socket. While the liner does providecushion for the user, and the suspension capabilities of this designwork very well, it is but an iteration of conventional socketapproaches, and fails to truly accommodate for volume changes in theresidual limb.

Additionally, unlike Alley, Cornell, or Hurley's disclosure, our designdoes not require a proximal brim as is commonly used. Unlike any otherinterface design, we can effectively have a brimless socket interface,since this design is the only one which does not truly encapsulate thelimb with a structure about the circumference of the entire limb.Instead, this disclosure may have floating elements which may bemodularly and adjustably tightened against the limb.

Still further, the other socket designs including Alley, Hurley, andCornell, all utilize distal contouring of the limb within the socket,and as such bear a portion of the weight distally. Likewise, any weightbearing that is bore circumferentially around the limb extends directlyto the distal attachment area. This invention however may utilize anon-weight-bearing distal end, and any force through the body of thelimb may be bore through the stabilizing unit alone to the distalattachment area. By doing such, the size of the interface can bemodularly adjusted circumferentially in real-time by the end user.

Any contouring of the interface about the distal end of the limb maycome through compliant materials, versus rigid structure, as used byAlley, Hurley, and Cornell. The distal end of this invention may usemore of a hammock-type fit with the contouring of the distal end to bemodularly adjusted to the user, through compliant materials that matchto the user, versus the user having to match to a pre-formed shape onthe distal end of a conventional socket. Spanning fabric to create adistal end, if one is used, ensures comfort, and that there is not toomuch force applied in that area.

An open distal end, or a modularly adjustable distal end throughcompliant materials allows for open wounds on the distal end of the limbto be un-enclosed, and to promote healing. As such, this invention couldbe applied to a new amputee, quickly after the amputation, or to a userwho needs to have their distal end de-weighted for healing purposes. Anopen air design makes for the skin environment to be significantlyhealthier, versus the conventional hostile interface environment ofconventional sockets that encapsulate the limb in a hot, moistenvironment.

Even if weight is applied to the distal end of this invention, it isestimated that a relatively small amount may be in contact there, with apredominant amount, likely above 90% to be applied through thestabilizing unit, and its opposing force coupling means.

Likewise, this invention could be applied in developing nations, wherethere is a need for a modular prosthetic design that would not requiretime consuming an expensive custom fabrication processes, materials, andequipment. Through using off-the-shelf modular kit components,prosthetics can now be fit, either locally or in developing nations,inexpensively. And, since this invention offers so much modularity tofit various users, and fit with them with increased comfort and control,the end user's life is enhanced. Each of the elements of this disclosurecan be offered in a kit set, including the connectors, stabilizing unitand force distribution anchors, etc., to allow for quick and accuratefitting of prosthetics.

In each of the above prior art, conventional casting, modification, anditerative fitting evaluations are required.

SUMMARY OF THE INVENTION

The present invention relates generally to a new and improved prostheticinterface design, and method of producing. In particular, the presentinvention is a new and improved method of providing control and comfortwithin a prosthetic device in a more efficient and effective manner.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in this application to the details of construction and to thearrangement of the components set forth in the following description orillustrated in the drawings. The invention is capable of otherembodiments and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of description and should not beregarded as limiting. As such, those skilled in the art will appreciatethat the conception, upon which this disclosure is based, may readily beutilized as a basis for the designing of other structures, methods andsystems for carrying out the several purposes of the present invention.It is important, therefore that the claims be regarded as including suchequivalent constructions insofar as they do not depart from the spiritand scope of the present invention.

Accordingly, titles, headings, chapters name, classifications andoverall segmentation of the application in general should not beconstrued as limiting. Such are provided for overall readability and notnecessarily as literally defining text or material associated therewith.

Further, the purpose of the foregoing abstract is to enable the U.S.Patent and Trademark Office and the public generally, and especially thescientist, engineers and practitioners in the art who are not familiarwith patent or legal terms or phraseology, to determine quickly from acursory inspection the nature and essence of the technical disclosure ofthe application. The abstract is neither intended to define theinvention of the application, which is measured by the claims, nor is itintended to be limiting as to the scope of the invention in any way.

It is therefore an object of the present invention to provide a new andimproved method of fitting prosthetics to those with limb loss.

It is a further object of the present invention to provide a prostheticinterface that is simpler and more consistent to fit to the user.

It is a further object of the present invention to provide a prostheticinterface whose fit is measureable, quantifiable, and repeatable.

It is a further object of the present invention to provide a prostheticinterface that is user adjustable.

It is a further object of the present invention to provide a prostheticinterface that is more breathable.

It is a further object of the present invention to provide a prostheticinterface that is lower profile under clothing.

It is a further object of the present invention to provide a prostheticinterface that is lighter in weight.

It is a further object of the present invention to provide a prostheticinterface that is modular and repairable.

It is a further object of the present invention to provide a prostheticinterface that can be fabricated less expensively and quicker.

It is a further object of the present invention to provide a prostheticinterface that uses compliant structures versus rigid or semi-rigidstructures.

It is a further object of the present invention to provide a prostheticinterface that truly accommodates for volume and shape changes of thedynamic underlying body.

It is a further object of the present invention to provide a prostheticinterface that provides gradual transitions of forces at its trim lines.

It is a further object of the present invention to provide a prostheticinterface that does not encapsulate the limb in the same manner asconventional designs.

It is a further object of the present invention to provide a prostheticinterface that captures the lost biomechanical and neuromuscularconnection between the limb and the user.

It is a further object of the present invention to provide a prostheticinterface to better control underlying bone position within the socket.

Another object of the present invention is to provide a new and improvedsystem which provides some of the advantages of the prior art, whilesimultaneously overcoming some of the disadvantages normally associatedtherewith.

These together with other objects of the invention, along with thevarious features of novelty that characterize the invention, are pointedout with particularity in the claims annexed to and forming a part ofthis disclosure. For a better understanding of the invention, itsoperating advantages and the specific objects attained by its uses,reference would be had to the accompanying drawings and descriptivematter in which there are illustrated preferred embodiments of theinvention.

BRIEF DESCRIPTION OF THE PICTORIAL ILLUSTRATIONS, GRAPHS, DRAWINGS, ANDAPPENDICES

The invention will be better understood and objects other than those setforth above will become apparent when consideration is given to thefollowing detailed description thereof. Such description makes referenceto the annexed pictorial illustrations, graphs, drawings, andappendices.

FIG. 1A generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 1B generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 1C generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 1D generally illustrates an embodiment of an attachment meansconnected to an embodiment of a force distribution stabilizer, viewedfrom a perspective angle.

FIG. 1E generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle, using compliant forcedistribution stabilizer structure with other compliant material spannedthere between.

FIG. 1F generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle, using a less compliant forcedistribution stabilizer structure with other compliant material spannedthere between.

FIG. 1G generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle, using a form holdingstructure spanned between force distribution stabilizers.

FIG. 1H generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 1I generally represents possible cross sections of a proximaltop-down view of an embodiment of the stabilizing unit 102, as may beaffixed to the medial or lateral aspect of the transfemoral limb.

FIG. 2A generally illustrates an embodiment of a compliant structure asmay be used for the gluteal fold area.

FIG. 2B generally illustrates an embodiment of a compliant structure asmay be used for the gluteal fold area.

FIG. 3 generally illustrates another embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 4A generally illustrates another embodiment of a transfemoralsocket interface, viewed from a perspective angle.

FIG. 4B generally illustrates another embodiment of a transfemoralsocket interface, viewed from a perspective angle.

FIG. 5 illustrates an embodiment of the prior art, using an encapsulatedsocket interface.

FIG. 6A generally illustrates another embodiment of a transfemoralsocket interface, viewed from a perspective angle.

FIG. 6B generally illustrates a close up view of an embodiment for adistal femoral stabilizing unit.

FIG. 7 illustrates the human anatomy, and the desired femoral angle inparticular.

FIG. 8 illustrates various embodiments of prior art showing theevolution of transfemoral socket interface designs.

FIG. 9 illustrates the human anatomy as it fits within one embodiment ofconventional prior art socket interface designs.

FIG. 10 illustrates another embodiment of a transfemoral socketinterface, viewed from the perspective angle.

FIG. 11 illustrates the benefits of distributing forces through usingcompliant materials.

FIG. 12A illustrates another embodiment of an interface, viewed from theperspective angle.

FIG. 12B illustrates another embodiment of a transfemoral interface,viewed from the perspective angle.

FIG. 12C illustrates another embodiment of an interface, viewed from theperspective angle, for use in upper extremity.

FIG. 12D illustrates another embodiment of a prosthetic interface,viewed from the perspective angle.

FIG. 13 generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle, being worn by a user.

FIG. 14 generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle, being worn by a user.

FIG. 15 generally illustrates an embodiment of a transfemoral socketinterface, viewed from a perspective angle.

FIG. 16 is a perspective view of a distal attachment embodiment.

FIG. 17 is a perspective view of an embodiment of a prostheticinterface.

FIG. 18 is a cross section view of an embodiment of a pad.

FIG. 19 is a cross section view of an embodiment of a pad.

FIG. 20 is an embodiment of a surface texture on a pad.

FIG. 21 is an embodiment of a surface texture on a pad, which may beused for suspension or control within a device.

FIG. 22 is an embodiment of an application of using such pads within anexisting socket.

FIG. 23 is a perspective view of an embodiment of the disclosedinvention in a splayed open position.

FIG. 24 is an embodiment of a connector with incremental numbersdesignating its position.

FIG. 25 is an embodiment of a connector with incremental numbersdesignating its position.

FIG. 26A is an embodiment of a fitting component kit that may be used tofit and align a prosthetic socket and its anchor struts to a user.

FIG. 26B is an embodiment of a fitting component kit that may be used tofit and align a prosthetic socket and its anchor struts to a user.

FIG. 27 is an embodiment of a mounting plate with infinite adjustabilityin rotary position.

FIG. 28 is an embodiment of a distal mounting plate that may be modifiedin its angle to connect an anchor strut to a distal end.

FIGS. 29A-29E generally illustrates various embodiments used in atranshumeral application.

FIGS. 30A-30E generally illustrates various embodiments used in atransradial application.

FIGS. 31A-31G generally illustrates various embodiments used in atranstibial application.

FIG. 32 illustrates the use of a gel liner or the like with anembodiment of a socket interface.

FIG. 33 illustrates a schematic of a swing brim webbing and materialsfor assembly.

FIGS. 34A-34D illustrate lateral, posterior, medial, and anteriorassembly of a socket-less socket and swing brim around a conventionalflexible inner socket, to provide additional conformity for a user.

FIGS. 35A-35D illustrates lateral, posterior, medial, and anteriorproposed trim lines of a flexible inner socket compared to conventionalsocket trimlines.

FIGS. 36A-36D illustrates lateral, posterior, medial, and anteriorproposed trim lines of a conventional frame as trimmed down toaccommodate a swing brim.

FIGS. 37A-37D illustrates lateral, posterior, medial, and anteriorproposed assembly of a conventional socket with integrated swing brimafter trim lines of the conventional inner socket and conventional frameto accommodate a flexible swing brim.

FIG. 38 illustrates a general schematic of an embodiment of a modularprosthetic socket in which sub-components may enable definedconfiguration assembly.

FIGS. 39A-39C illustrate a possible work flow of software which may beused to input limb measurements and output a defined assemblyconfiguration.

FIGS. 40A-40C generally illustrates another preferred embodiment inaccordance with the current invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designatecorresponding structure throughout the views, and referring inparticular to FIG. 1A, numeral 100 generally refers to a new andimproved compliant based transfemoral level prosthetic socket apparatus,assembly and/or system, hereinafter referred to generally andcollectively as invention 100.

Of note, invention 100 may be generally shown by example in aconfiguration for an individual missing a right or left leg or portionthereof at a knee disarticulation or transfemoral level. It isunderstood that such configuration is for example purposes only and thatsuch should not be considered limiting and a left or right sideconfiguration is also considered. It is further understood thatinvention 100 may be used where the level of amputation may dictate adifferent configuration than transfemoral or knee disarticulation level,such as but not limited to transtibial, transradial, transhumeral, orother levels either prosthetically, orthotically, or with exoskeletalrobotics—all of which may be considered as human/machine connectivity.The terms should not be considered limiting the invention nor thegeneral shape and configuration depicted in the drawings. Invention 100may encompass many embodiments, as generally illustrated in the variousfigures, and should not be considered limiting where any particularfigure depicts one embodiment of invention 100, as there are variouselements, embodiments, and user specific requirements.

In a preferred construction, there may be a distal attachment area orstructure 101 for mounting other prosthetic components to, such as butnot limited to knees, feet, stubbers, connectors, or otherconventionally used components which are used distal to a socketapparatus. The particular attachment means may be any conventionallyused means, including plates, screws, gunk, and others.

Extended from the general attachment area 101 may be a stabilizingunit(s) 102. The stabilizing unit 102 may be affixedly connected to thegeneral attachment area, or may utilize elements floating in relationthereto. The particular contouring of the stabilizing unit 102 may beformed in any number of orientations and trim line cutouts, includingvarious widths, heights, contouring, shape, attachment means, and othersuch elements. The stabilizing unit 102 may extend along any particularside of the limb, including but not limited to along the medial side,lateral side, anterior side, posterior side, or at an angle from oneside distally, to a different side proximally.

Conventional transfemoral interfaces typically largely circumferentiallywrap around the limb, and provide a rigid support under the tuberosityarea, as illustrated in FIG. 5. With invention 100 however, in apreferred embodiment, the stabilizing unit 102 may generally extend upthe medial aspect of the limb near or between the quadriceps andhamstring muscle groups, or up the lateral aspect of the limb near orbetween the hamstring muscle group and the quadriceps muscle group, oralong the anterior aspect of the limb near or between the hamstringsmuscle group and adductor muscle group. The anatomical contouringbetween those groups may allow for a slight twist to the stabilizingunit 102 as it moves proximally up the limb, as is illustrated in FIG.1C.

In a preferred embodiment, the stabilizing unit 102 may be relativelyrigid to allow for support of the forces imposed through the device. Thewidth of the stabilizing unit 102 may be tailored to individual user'sneeds, and those illustrated in the figures should not be consideredlimiting.

In a preferred embodiment, there may be an additional stabilizing unit102B, which may generally run proximally from the attachment area up therelatively opposing aspect of the limb. Additional stabilizing units maybe used, and should not be considered limiting. While this element maynot be required to achieve the desired outcomes, it may provide foradded stability. In such an example, this stabilizing unit may have asimilar rigidity as the medial stabilizing unit 102. Each stabilizingunit may generally contour according to the shape of the underlyinglimb, or may be relatively generic in shape, contouring to a genericlimb. The particular placement, shape, rigidity, number, material, andother characteristics of such a stabilizing unit may be modified on acase-by-case basis according to the particular user's needs.

While the material selection may allow for rigidity of the stabilizingunits, because of their inherent shapes they may exhibit somewhat offlexibility in certain directions. To create a solid enough structurefor supporting the user through the prosthetic interface, connectormeans may be used to attach either a stabilizing unit to itself, or toattach two or more stabilizing units to each other. This may beaccomplished through using compliant members.

Instead of using an encapsulated socket as in conventional fittingapproaches, the invention 100 may use fabric based or compliant basedmembers to encapsulate portions of the limb, or may encapsulate asignificant portion of the limb.

Referring specifically to FIG. 1A, stabilizing unit 102 may generallycontour to a limb. In such an example, it may as well incorporate otherelements such a padding or foam to help further contour to the specificunderlying anatomy of a user. Stabilizing unit 102 may as wellincorporate modular elements to modify its height, angle, length, orother adjustable aspects.

In general, stabilizing unit 102 may offer general or specificcontouring for the ischial seat toward its proximal end, as in theuse-case of it running along the general medial aspect of a transfemorallimb, or may utilize a sub-ischial design. It may as well wrap aroundthe distal aspect of a residual limb, as illustrated in distal area orsection 103, whereby a relatively small area is encapsulated to seat theresidual limb into. Or, the distal area 103 may offer a larger areawhere the distal aspect of the residual limb may be encapsulated.

In a preferred embodiment, the predominant amount of force may be takenproximal to the distal end of the limb, and the distal end of the limbmay have a relatively small amount of total force, or even no force, asillustrated in FIG. 1A. In such a case, the majority of the loadingforce through the system may be along the stabilizing unit, proximal tothe distal end. Where minimal force may be encapsulated within thedistal aspect of the limb, such an area may extend for a portion up thesocket interface length, and may resemble the lower portion of aconventional socket interface in shape. Likewise, distal area 103 mayextend the full length up the socket interface shape for a flexibleinner socket as is traditionally used for such level of amputation, andmay be able to be utilized on an existing flexible inner socketinterface. Even further, distal area 103 may utilize compliant materialsto encapsulate the distal end of the residual limb, thereby hammockingthe distal end of the limb in a compliant material, which may include afabric or other compliant materials.

FIG. 1I generally represents various possible cross sections of aproximal top-down view of an embodiment of the stabilizing unit 102, asmay be affixed to the medial or lateral aspect of the transfemoral limbfor instance. Such stabilizing unit may utilize one or more componentsof the stabilizing unit to be affixed to the distal attachment area 101,which may be modularly adjustable or not modularly adjustable inangulation, length, or position, or other orientations as may bedesirable. Extended from the distal attachment area 101 may bestructural elements, which may include tubes 114, poles, struts 115,padding 116, or other such pieces, including any combination thereof, ormay be custom fabricated as a single or multiple pieces, any combinationof which used individually or together which may have enough structuralintegrity to support the necessary forces to generally support the user.Such pieces as a unit may help hold orientation about the limb, and maygenerally contour with respect to long bone 117, generally causing aportion of the stabilizing unit to reside anterior to the long bone(anterior lateral, or anterior medial as the case may be), and oneportion of the stabilizing unit to reside posterior to the long bone(posterior lateral, or posterior medial as the case may be). By doingso, the long bone may generally be held in a certain orientation withrespect to the stabilizing unit, as the force distribution anchors maybe tightened toward it, generally reducing the medial/lateral dimensionof the interface. Stabilizing unit may be constructed of at least oneindependent component(s), with any such various components connected tothe distal attachment area independently, and as a total workingtogether as a unit. One example illustrated in FIG. 11 demonstrates theuse of two independent components attached to the distal attachmentarea. Another example illustrates a single component attached to thedistal attachment area. And a third illustration demonstrates a hole cutout in a single component, so that the distal end of the long bone maybe relieved. Such illustration examples should not be consideredlimiting, as one or any other number of the examples may be used, orused in combination through the length of the stabilizing unit.

Force distribution anchor 105 and 106 may be positioned around thegeneral opposing side of the limb, and may utilize a span of distancebetween their sub-components. The distance between force distributionanchor components 105 and 106 may be modularly adjustable, and mayutilize a compliant material 107 between anchors 105 and 106. The termcompliant materials should not be considered limiting and in general mayinclude a range of compliancy. For example, this may include materialssuch as fabric or mesh fabric, as well as materials like foam padding,fabric straps, VELCRO, or thermoplastic ladder straps for typicalratchet mechanisms—each of which are compliant, and may offerappropriate levels of compliancy for different use-cases. Some use-casesrequire very flexible compliancy, whereas other use-cases may require aform-factor to be generally held, while still being able to beconforming under load. In general, the term compliant shall signify anymaterial that is conforming to the body under the given load that isimposed on it, and which conforms an appropriate amount for the givenuse-case. Force distribution anchors 105, 106 may be fabricated of arelatively stiff material, or may be highly compliant. In a preferredembodiment, they may be stiff enough to hold their form with respect tothe limb, and may be used as an anchor point for attachment means withinthe system. The force distribution anchors 105, 106 may be relativelynarrow long shapes as illustrated in FIG. 1A or may offer other variousshapes, such as but not limited to that which is illustrated in FIG. 10.Their specific shape should not be considered limiting, as they may be amodular component, or may be customized to fit a particular user, whomay have particular shape dependent needs. Force distribution anchors105, 106 may as well utilize markings to help a practitioner determineappropriate trim patterns or hole patterns for modularity. They may alsooffer spring response, so that during ambulation on the device, they mayprovide shock absorption for the user.

In another embodiment, the force distribution anchors 105, 106 may befabricated from flexible materials, such as but not limited to wires, tomanage the forces for their intended function.

Attached to the force distribution anchors 105, 106 may be adjustable ornon-adjustable connectors 108 that may connect the force distributionanchors to the stabilizing unit. These connectors may allow the forcedistribution anchors position to be modularly adjustable with respect tothe stabilizing unit. There may be any number of connectors, andconnector types that may be utilized, and the particular use ofconnectors in the figures should not be considered limiting. Theconnectors may even utilize fabric spanned to accomplish the same.

In a preferred embodiment, the connectors may incorporate areas whichmay maintain a certain curvature shape which may generally resemble thearc around a residual limb, whereas to help prevent the connectors fromroping across the limb. In such an example, the connectors may utilizeincorporated more rigid elements which may as well provide some springresponse during ambulation, or may be rigid enough to not allow springresponse. In general, such features may help prevent the connectors fromdigging into or roping into the limb as they arc around the curvature ofthe limb. Likewise, a broader material may be used to help spread theload across, thereby preventing them from digging into the limb.

FIG. 1B illustrates such an embodiment, where broad compliant fabric 109or other compliant materials may be used to connect the forcedistribution anchors to the stabilizing unit. Such span of compliantmaterial may be attached with any conventional attachment means, andsuch material may utilize connector means that may be modularlyadjustable to allow for ease of tightening to a desired length.

FIG. 1D generally represents an embodiment of a force distributionanchor with connectors attachments on one side, in order to give arepresentation of how they may integrate within such an element. In suchan example, there may be various materials used on within the forcedistribution anchor to allow for certain areas 111 to be more rigid andcertain areas 112 to be more flexible, to allow for an effective taperedtransition of forces as it sits around the body. Additionally, as fabricor other compliant materials may be stretched from one stabilizing unitto another, and so forth, the fabric itself may create the softtransition from one structural element to another.

In addition, the connector means which may be used to connect eitherforce distribution anchors with each other, or force distributionanchors to stabilizing unit may have semi-rigid elements or customizableelements to provide a set curvature. In doing so, it may help preventthe connector means from roping into the soft tissue as they curvearound the limb. Further, the integration of other compliant materialssuch as fabric to span there between may be used to prevent roping, asit would effectively spread the forces over a broader surface area.

In between the force distribution anchors may be compliant fabric 107,which may or may not be modularly adjustable, to determine the span inbetween the force distribution anchors. Likewise, a rigid, semi-rigid,or other flexible means may be used to connect the force distributionanchors together, including forming the force distribution anchorstogether as a single continuous piece with like or dislike materials. Itshould therefore be understood the force distribution anchors mayfunction as a unit, giving general opposing force to the stabilizingunit, and as such, may be considered a functioning single unit.

FIG. 1E generally represents an embodiment of how compliant fabric,fabric mesh, or other compliant materials may be spanned between a forcedistribution anchor system of one continuous piece. In such an exampleof embodiment 1E, the fabric may generally be bridged somewhat similarto a hammock between the force distribution anchor elements. Suchassembly may utilize connection means to the stabilizing unit 102, ormay use force distribution cabling run through such fabric to create a“paddle” of fabric. The perimeter outline shown in the figure maygenerally follow what becomes the curvature of the fabric paddle, as theforce distribution cabling may be stretched there between in a certainconfiguration to cause the paddle to represent a pringle-shape, or othershapes may be utilized as well. The force distribution cabling may becomplaint, though may cause the structure, which includes the compliantfabric stretched there between, to create a structural unit. Suchstructure may additionally include attachment means 110 to connect tothe stabilizing unit 102. Additional fabric may be spanned between thepaddle and the stabilizing unit 102. Additionally, other attachmentmeans may be used to span to connect between as well.

FIG. 1F is similar to FIG. 1E, except that the force distributionanchors may be of a more structural nature formed as a continuous piece,or as a combination of multiple pieces configured to create a structure.FIG. 1E may represent a compliant continuous piece, or combination ofpieces. Both examples may utilize fabric or other compliant materialspanned in between to further spread out the load across the user'slimb.

Still further FIG. 1G may represent an embodiment where the forcedistribution anchors may be connected together with a semi-rigid strutelement, which may alternatively be semi-flexible, which may generallyspan away from the limb, so that as the force distribution anchors maybe pulled toward the main stabilizing unit with their connection means(not shown in the figure), the force distribution anchors may press intothe limb tissue. As such, there may also be fabric or other compliantmaterial spanned between the force distribution anchors in addition, allof which may be modularly adjustable in their varying orientations,positions, and general effective contouring about the limb, to modifyhow they interact with the soft tissue of the limb.

Referring to FIG. 1C, and of which may generally be relevant to andembodied within other embodiments as well, on the proximal end of theinterface, invention 100 may utilize a compliant structure to contouraround the underlying anatomy, which may generally run fromapproximately near, at, or posterior to the adductor muscle group regiontoward the proximal end of the interface connecting at or near thestabilizing unit 102, and run generally around the posterior, ormedial/posterior aspect of the limb toward the trochanter area of thelateral aspect of the upper thigh, which may attach to stabilizing unit102B, or may continue further around the limb back to the adductorregion connection point(s). In one embodiment, this element may simplyconnect the stabilizing unit to the posterior lateral force distributionanchor area, whereas it may generally be positioned near the glutealfold region, to provide at least one of contouring, comfort, and controlof the device.

FIG. 1H generally represents an embodiment where stabilizing unit 102may generally extend from distal attachment area 101 proximally up thegeneral lateral aspect of the limb, and whereas the force distributionanchor 105, 106 may generally extend across the medial aspect of thelimb. As such, the anterior force distribution anchor may generally sitnear or between the quadriceps muscle group and the adductor musclegroup, while the posterior force distribution anchor may generally sitnear or between the adductor muscle group and the hamstring musclegroup. In such an embodiment, the femur may generally be pulledlaterally toward the stabilizing unit, and such stabilizing unit mayexhibit a general angulation similar to the desired femoral angle.

Embodiment 1H may generally utilize a load bearing compliant member orstructure 200, which the user may rest into during load bearing. Suchunit may be incorporated within the force distribution anchor assemblyor may be independent from such. By being compliant, such unit mayprovide increased comfort for the user, versus the traditional rigidischial/ramus/tuberosity shelf found in conventional transfemoralsockets. As such, this element may function somewhat similar to themedial/posterior aspect of a rock climbing harness, in that some of theweight bearing of the unit may be bore in soft compliant materials,versus rigid structures. The lateral orientation of the stabilizing unitmay allow the compliant member 200 generally be supported in the correctorientation with respect to the body.

This compliant member 200 may be utilized with stabilizing unit alone,or may incorporate force distribution anchors to assist in managing thedirection and orientation of the forces through the system. It has beenfound clinically that the integration of the force distribution anchorswithin such an embodiment may provide added control and comfort.

In such an embodiment, the stabilizing unit extended up the generallateral aspect of the limb generally may make it more conducive for moreof a generic shape to fit to a wide variety of limbs, versus having tobe custom fabricated.

In an embodiment where stabilizing unit may extend up the lateral aspectof the limb, an opening 113 may exist in such stabilizing unit to allowfor the long bone and/or tissue surrounding the long bone to fit within.As such, the distal end of the long bone may have space to press into aspace where there is no rigid structure. This space may be spanned withno material, or may be spanned with compliant fabric to further controltissue flow. It is understood that such opening may be in any width,height, contouring, or shape as may be best suited for the particularpatient, or for human anatomy as well. Stabilizing unit may exist invarious subcomponents to allow for such opening to be created, includingbut not limited to disconnected anterior and posterior support sections,each of which may be connected to a distal and/or proximal end together,or to other such structure, including structure 101. Such opening mayalso be used where the stabilizing unit resides along the medial aspectof the limb.

In general the term medial and lateral are in particular reference to atransfemoral use-case, and for other use-cases such as transtibial,transradial, transhumeral, or for orthotic applications, the particularorientation of the compression may best be utilized in an orientationother than medial/lateral, such as but not limited toanterior/posterior, and as such the general terminology should not beconsidered limiting, as the terms medial/lateral for the stabilizingunit and force distribution anchors general opposing force directionsare for example purposes only for the transfemoral use-case, to allowone skilled in the art to better comprehend how they may relate with oneanother.

Amongst FIGS. 1A-1I general embodiments, force distribution anchors maygenerally float with respect to the stabilizing unit 102. By doing such,their circumferential position about the limb may be modularlycontrolled, allowing for full accommodation to the user's limb size andshape. Furthermore, if two force distribution anchor components arejoined together as one unit, they may be positioned on either side ofthe long bone of the limb segment, allowing the more compliant materialspanning in between, which may also be an area without material spannedin between, to be positioned over the long bone. By doing such, theforce distribution anchors may effectively help lock the bone positionsuch that the long bone is generally controlled during ambulation,through using the device. The compliant material which may span betweenthe force distribution anchors may allow for the sensitive distal end ofsuch bone to be free of contact with any rigid or semi-rigid surface.One component of the force distribution anchor may generally reside onthe anterior side of the long bone (anterior/medial, or anterior/lateraldepending on orientation of the stabilizing unit being laterally ormedially orientated), and one component of the force distribution anchormay generally reside on the posterior side of the long bone(posterior/medial, or posterior/lateral depending on the orientation ofthe stabilizing unit being laterally or medially oriented).

As the force distribution anchors may be tightened toward thestabilizing unit 102, it may generally shorten the medial/lateraldimension of the interface, as in the case of using this on a user witha transfemoral amputation for instance. In such a case, the long bonemay be generally pulled toward the stabilizing unit, and maintained insuch a position, as is referenced in FIG. 7 with the desired femoralangle. To accomplish this, the limb tissue may need to be displaced, inwhich the anterior and posterior dimensions may allow for the materialto be displaced into, so that the medial/lateral aspect of the interfacecan be tightened to control the bone. The force distribution anchors maywork in coordination with one another as effectively one unit lockingthe femur from the anterior and posterior sides, along with any materialthat may connect between the two, to control the position of the longbone.

It should be understood that while the invention is described in theseconfigurations. Further, embodiments from FIGS. 1A-1I may be utilized onother levels including transhumeral, transradial, and transtibial levelswith similar advantages as for a transfemoral level. Still further,embodiments illustrated in FIGS. 1A-1I may also be utilized in similarorthotics and exoskeletal robotics levels to control the underlying limbsegments. The shapes of the stabilizing unit and force distributionanchors may embody many various configurations, and those illustratedand discussed should not be considered limiting. The general principleshow such pieces may connect together, and how the pieces may worktogether to control the limb can be accomplished with a variety ofconfigurations.

Referring to horizontal section or attachment means 208 as illustratedin FIG. 1C, the compliant structure 200 may generally be used to supportload bearing of the user within the device. This element may be utilizedin any of the embodiments, and generally may be spanned near or as theproximal posterior connector, running along the gluteal fold region.Instead of solely supporting the user's weight volumetrically throughthe whole limb as in conventional devices, a sizable amount of thevertical loading may be bore through such compliant member, andspecifically it may run near the gluteal fold region to help accomplishthe soft tissue and anatomical contouring as loading. Through using itin the configuration where it may extend further under the medial aspectof the limb as well, it may utilize ischial loading as well. This mayfunction similar to how a rock climbing harness suspends its user,though may be accomplished here for use in prosthetics interfaces. Thiscompliant member may further extend to or past the ischial area, so thatsuch area may be supported by a compliant member, similar to how a rockclimbing harness may function, instead of using a rigid or semi-rigidseat as in conventional socket interface designs.

FIGS. 2A-2B generally show a preferred embodiment of such compliantstructure 200, here specifically depicted as a gluteal stabilizer. Thestructure may encompass adjustable attachment means on its medial andlateral sides. These attachment means may be any commonly used in theindustry, and those depicted should not be considered limiting, but mayinclude user adjustable means, or non-user adjustable means, or acombination of both. The compliant nature of the compliant structureitself should, in a preferred embodiment, lend itself to a formed shape,while maintaining compliancy.

The attachment means may allow for adjustability in fit throughtightening or loosening the compliant structure, changing thecircumferential dimension of the interface. It may also be used toconnect the stabilizing unit(s) which may provide added structuralsupport of the interface unit.

It may encompass various materials of various degrees of compliancy tomaintain such, including but not limited to fabric, foam, plastic, orother generally compliant materials. In general, the compliant structuremay conform around or near the gluteal fold area of the body on theposterior side of the body. It may also offer a level of arc orconcavity 203, which may help to contour into the soft tissue betweenthe hamstrings and the buttocks.

The compliant structure 200, in a preferred embodiment, may haveasymmetrical contouring as depicted in curvature or section 201 versuscurvature or section 202, and curvature or section 204 versus curvatureor section 205. In such an example, the curvature or section 201 may benotably different than that of curvature or section 202 to contour overvarious users differently. Some users may benefit from curvature orsection 202 positioned on the distal aspect of the structure.Conversely, other users may benefit from the unit being positioned 180degrees, with the curvature or section 201 positioned on the distalaspect of the strap. Having a reversible design may allow for betteruser contouring and success.

Likewise, asymmetrical contouring of arc 203 may benefit various users.Positioning the unit with the broader curvature of section 205 on itsdistal aspect may benefit those patients with larger soft tissue areas,which positioning the unit such that section 205 is positioned on itsproximal side may benefit users with other body shapes.

The compliant materials of invention 100 may as well benefit fromaccessory elements such as integrated nanotechnology or othertechnologies to provide various characteristics that benefit thefunctional or user performance or experience with the device. These mayinclude, but are not limited to, sensors, hygiene elements,antimicrobial elements, water repellency, or others.

This structure may as well integrate in purposed contouring to fitaround the tuberosity and ramus areas of the body. This area may offerdiffering degrees of conformity or rigidity, in order to provide thenecessary support for the user's needs.

There may be a generally similar compliant structure connecting themedial stabilizing unit 102 to lateral stabilizing unit 102B, as well asothers as integrated. This may be used to help provide added structuralstability of the interface unit, as well as provide sufficient comfortfor the user on the proximal anterior aspect of the interface.

FIG. 3 generally illustrates an alternative embodiment of the invention100 where the medial stabilizing unit may generally contour up themedial aspect of the limb, and may further contour around or near thetuberosity area, providing support through the stabilizing unit 102,versus directly through the compliant structure 200. There may also beanother connector means running along the anterior connecting thevarious stabilizing units. Additional compliant material may be spannedin between across and around the general circumference of the limb, tohelp control tissue and connect to the stabilizing unit(s).

FIGS. 4A and FIG. 4B generally illustrate similar configurations asshown in FIGS. 1A and FIG. 3, although utilizing just medial stabilizingunit 102, versus in combination with a lateral or other numbers ofstabilizing units. In such an example, other compliant members mayadditionally be integrated to prevent user movement within the device incertain orientations of movements. One such example of such may be toconnect the proximal lateral aspect of the proximal circumferential unitas show, to the distal lateral aspect of the anchor stabilizing unit toprevent the circumferential unit from migrating proximally. This can becontrolled with a compliant strap, versus a rigid element. Further areasof the open areas may be spanned with other compliant materials,including but not limited to compliant fabric mesh. These othermaterials may be used to provide control of the tissue of the limb. Theuse of such circumferentially spanned fabric may help to encapsulate andcontrol the limb tissue through stretching it tighter or looser incertain areas and directions about the soft tissue. The illustrations inFIG. 4 may as well utilize force distribution anchors as illustrated inother embodiments as well. These are not shown in this figure forsimplification purposes, and therefore should not be consideredlimiting.

FIG. 6A generally illustrates the integration of a femoral stabilizerunit 600 integrated within the invention 100. In such an example, thegeneral dynamic characteristics of the femoral stabilizer unit may besimilar to the compliant structure 200, though may contour specificallyaround and proximal to the distal aspect of the femur bone. Itscontouring may generally utilize 3-dimensional contouring sections tobest contour around the underlying anatomy. It may offer loweredsections or attachment means 208A and 208B to post either side of thefemur bone, and a raised section 209 in between to allow the actualdistal femur to not be impinged.

Adjustable connectors 210 may be used to allow for user adjustabletightening of the femoral stabilizer. The purpose of such a compliantstructure may be used to not only post the sensitive distal aspect ofthe femur from the interface, but just as importantly, may help maintainfemoral stability and femoral angle, thereby providing for a greaterbiomechanical stability of the femur within the interface. This willlead to greater control and stability for the user, as their bonystructure within the residual limb will be more closely locked to theprosthetic movement. Such a femoral stabilizing unit may be usedindependently from, or in combination with force distribution anchorstructure.

This femoral stabilizing unit structure may be attached at more than onelocation on each side, and may utilize other attachment sections (notshown in the figures) to provide increased positional stability of theunit with respect to the user's limb orientation. It should beunderstood that the illustration described in FIGS. 6A-6B may befunctionally similar to that described in FIGS. 1A-1I, whereas the longbone may be more advantageously controlled by a connected, yet floating,element which may contour around the long bone in a way as to controlits movement within the device.

Such an element may help maintain femoral stability within the design.FIG. 7 illustrates the femoral angle that should be maintained within asocket interface device. However, due to the cut end of the femur bonenot being connected to the rest of the limb, the femur tends to moveanterior/posterior, as well as medial/lateral during walking. Thismovement decreases stability and gait efficiency.

FIG. 8 demonstrates several of the evolutionary iterations oftransfemoral socket design that have been used to help maintain femoralstability, as well as comfort and provide control of the limb. From leftto right, these include: Plug fit socket, quad socket, Sabolich socket,MAS socket, Hi-Fi socket. Besides the Hi-Fi, each uses a hydrostaticfit, and all versions rely on enclosing the limb within an encapsulatedthermoplastic socket, and none provide volume accommodation. Of these,only the Hi-Fi socket does an adequate job controlling the femur withinthe soft tissue. As one can see, the same anatomy of the human thigh canfit within many different shapes, and all of which may allow a user toeffectively walk on their prosthetic device. This large variety offitting methods is somewhat due to the compliant nature of the softtissue of the thigh, however, each design offers different degrees ofcomfort and bony control. This may also suggest that the stabilizingunit as generally illustrated in FIG. 1 and others may be anoff-the-shelf shape, which may be somewhat customizable to the usereither through adjustment means or compliant materials incorporatedwithin such as padding, to allow for a conforming and comfortable fit.

FIG. 9 generally shows how the muscles and bone fit within one versionof a conventional socket design, in this case, showing an antiquatedquad socket.

FIG. 10 shows an embodiment of invention 100 wherein the femoralstabilizing unit may be integrated within a vertical oriented forcedistribution anchor unit. Additionally, it may be integrated within astabilizing unit or may be generally floating and connected to a mainstabilizing unit via connectors. In such an example, there may be a mainmedial stabilizing unit, connected to floating anterior and/or lateralforce distribution anchors. There may also be other numbers orlocations, or contouring of such stabilizing units and forcedistribution anchors, and the illustrations should not be consideredlimiting.

In between the various force distribution anchors and stabilizing unitsections within the various embodiments may be a compliant fabric, whichmay include, but not limited to a mesh material. Such a material mayoffer breathability, coolness, lightweight, and durable design. In suchan example, it may help encapsulate the limb tissue, providing forincreased comfort and control. Even further, such compliant material mayhelp post the distal femur and may allow the distal femur to contactonly compliant fabric, versus rigid structure.

FIG. 11 demonstrates the benefit of integrating compliant fabric withinthe interface design, as it allows for a gradual transition from highforces to no forces. The fabric is not specifically illustrated in thefigures for simplicity, though would reside between the variousstabilizing elements, as may be integrated within the compliantfabric-based socket element. As a fabric may extend from a stabilizingelement, the underlying tissue may be controlled at the transitionpoints, allowing for gradual transitions of pressures, versus typicalsharp transitions as is typically found in conventional fitting methods.

In addition to the socket contouring as depicted in the variousillustrations, there may as well be a distal cup or distal socket areawhich the limb may reside (not shown in some of the illustrations). Thismay allow for any portion (from partial to full) of the limb to beencapsulated, allowing for suction or vacuum suspension to be achieved.This element may be fabricated with conventionally known methods and/ormaterials. Still further, the user may use a gel liner or othercompressive sock or the like in conjunction with invention 100, whichmay allow for suspension, and tissue encapsulation and control asdesired. The gel liner for example may be used independently or inconjunction with other flexible inner socket elements.

Invention 100 may be used in coordination with an existing socketdesign, or with a conventional flexible inner socket integrated, suchthat the force distribution anchor assembly may advantageously be usedto improve the fit of an existing socket, as well as minimize thecomplexity of fitting a conventional socket, as invention 100 may helpto improve modularity and adjustability of the fit around a user.

The compliant force distribution socket may encapsulate the limb withcompliant materials, such as but not limited to fabric mesh, and mayeliminate the non-breathable hot and heavy thermoplastic socket. It mayutilize isolated regions of compliant, yet stabilizing zones, and abroad distribution of forces to support the limb and minimize pointpressures.

Each may be connected with adjustable connectors to allow the user totension the tightness to a preferred comfort. The stabilizing unitsegments and the compliant fabric may be adjustable—allowing for theclinical fitting process to be modularly customizable to the user, aswell as user-adjustable for preferred security and comfort.

The medially oriented stabilizing unit may key into the soft limb tissuegenerally near or between the hamstrings and adductor muscle groups, anda lateral oriented stabilizing unit may generally position near orbetween the hamstrings and quadriceps muscle groups, and an anteriorstabilizing unit may generally position near or between the quadricepsand the adductor muscle groups. The various stabilizing units along withopposing force distribution anchors together may provide opposingforces, locking the limb in relation to the interface, and henceproviding an improved link between the intended musculature and bonystructure movement of the body with the movement of the prosthetic limb.The less the bone moves within the soft tissue, the better biomechanicaland neuromuscular control will be achieved, reducing energy expenditureof ambulation.

As each of the stabilizing units and force distribution anchors may beseparate, yet linked, there is an infinite amount of modularity and useradjustability, creating a fully customized fit, and ability toaccommodate for residual limb volume change. The predominant surfacearea of the interface may be open, or mesh fabric, allowing forbreathability and heat dissipation. It may, but not necessarily be,generally utilize conventional socket shape contouring, with the addedbenefit of adjustability between the various stabilizing unit segments.

This design may also allow for significantly lower trim lines at theproximal brim, and may not necessarily require specific brim elements asin conventional socket designs.

FIG. 12A generally illustrates an embodiment where the forcedistribution anchors may not float, but rather may be structurallyconnected. In such an example, force distribution anchors 1201 and 1202may generally run in an orientation along the long bone. In between themmay be modularly adjustable connector means, which may also includecompliant fabric. Connector means 1203 may allow the force distributionanchors to be pulled toward each other, tightening the interface aboutthe limb. As fabric may be spanned or stretched in between the anchors,any long bone movement that may tend to press lateral, as in the case ofa transfemoral amputee, may tend to push into the soft fabric, versus arigid structure. In this embodiment, the interface may be fabricated tobe slightly undersized for the user, thereby allowing it to haveinherent compression about the limb, and inherent bony control. As thesystem may be tightened to the user, it may provide added compression.In general, a tight medial/lateral compression may be used, to helpcontrol the bone, and allow the tissue to bulge out the other areas. Notillustrated in FIG. 12A, but is in FIG. 12B, at the distal end may be aconnector means to attach to other typical components used along withsuch a device. Such an embodiment may also utilize a vertical anchorstabilizer 1204 along its general medial side, as illustrated for atransfemoral use-case, to prevent flexing of the structure.Additionally, padding or other compliant materials may be integrated toadd comfort and conformability to the user.

FIG. 12B represents an embodiment as donned onto a transfemoraluse-case. This illustration does not show the connector means, but itshould be understood that they may be integrated into such a system.

FIG. 12C represents an embodiment as donned onto a transhumeraluse-case, and as may be used for non-prosthetic man/machine interfaceconnectivity.

FIG. 12D represents an embodiment as donned onto a transhumeraluse-case.

In each such case, the connector means 1203 may be used to draw theforce distribution anchors together, tightening the interface around thelimb, and providing control of tissue and bony anatomy.

Such embodiments may also be used on other use-cases includingtranstibial, and transradial levels, and all such correspondingorthotics levels to control the limb segments. In any such orthoticsuse-case obviously an open end may be used, as the limb may extend pastthe end of the device. Furthermore, any such embodiments in thisdisclosure may be used in exoskeletal robotics, as they are merelyadvanced orthotics devices.

FIG. 13 represents invention 100 donned onto a transfemoral amputeeuse-case. This illustration shows how the distal end of the interfacemay be contoured to the distal of the residual limb. This illustrationalso shows the proximal end of a flexible inner socket, gel liner, orother compressive sock 1301 to control tissue, as may be worn with thedevice.

FIG. 14 represents invention 100 donned onto a transfemoral amputeeuse-case. This illustration shows how the distal end of the interfacemay purposely be in non-contact with the distal end of the residual limbstructure. In such an example, the distal end of the limb may besuspended with compliant fabric 1401 to give a similar effect as a rigidstructure's support, but with compliant means. This fabric section maybe spanned from the stabilizing unit(s) and force distribution anchor(s)distally to their corresponding components proximally to provide ananchor for its attachment.

Likewise, such a system may be used for casting of a custom medial orlateral anchor, whereas the remaining elements of the invention 100 maybe integrated to such a casting jig, in order to cause the plaster whichmay be wrapped around the residual limb to be specifically contoured tothe underlying anatomy as the force distribution stabilizing units aretightened down to the user. Integrated fabric may assist in capturingthe contouring of the distal end within the casting process. Similarly,the fabric may be spanned around much of the limb, creating a hammockcontainment of the limb within fabric, replicating or replacing a rigidinterface that is conventionally used to hydrostatically manage the limbshape.

In an expanded modular embodiment, the stabilizing unit may be of afully modular or modular semi-customizable component, which may eitherattach directly to the limb components, or may attach to a customizeddistal connector, which may attach to the limb components, asillustrated in FIG. 15. It is also understood that other numbers offorce distribution stabilizers or anchor stabilizers may be used, andtheir shapes, sizes, orientations, and configurations illustrated in thefigures should not be considered limiting.

In such example, attachment means 1501 may be any attachment method toknown in the field, which may provide a structural attachment, and thatin the figure is meant for illustrative purposes only. In such anexample, the distal end of socket 1502 may be customized by the clinicalpractitioner, and modular stabilizing unit 1503 and force distributionanchors 1504 may be modularly connected within the system to make acomplete interface, along with other sub-components. As describedpreviously in FIG. 8, over the years there have been a number of socketdesign iterations which the human above knee limb can fit into, and allof which have radically different socket shapes. This tells us that thehuman thigh can fit within many different shapes, where the stabilizingunit may reside. As such, an off-the-shelf stabilizing unit may come invarious sizes, or may offer other compliant means such as padding, andmay generally offer a shape that resembles that of the underlyinganatomy, in which it may contour around. Likewise, there may be anynumber of stabilizing units which may be modularly connected to a commoncustomized distal attachment.

The embodiments represented may be custom fabricated, or may bepre-fabricated and sized to fit a variety of users, or may utilize acombination of both. Since they offer so much inherent modularity, aselect few sizes will fit a variety of sizes of users. Additionally,conventional suspension systems available within the field may be usedin conjunction with this design, including but not limited to distal cupor full length socket to provide vacuum or suction suspension, and whichmay be integrated into the invention.

Invention 100 may utilize at least one, possibly two, or more,stabilizing unit(s) to be modularly connected to distal base. In oneembodiment as illustrated in FIG. 16, stabilizing unit may have a rigidor semi-rigid section 1601 which may extend up the length of stabilizingunit, or may attach to a separate stabilizing unit section, which mayresemble the force distribution anchors in general shape orcharacteristics. Such base of the stabilizing unit may be connected withadjustable base 1602. Such adjustable base may utilize any adjustmentmeans known, and those illustrated should not be considered limiting. Inone embodiment, adjustable base may utilize a male to female pyramidsetup 1603, where stabilizing unit section may be modularly adjusted inangulation. The opposing pyramid section may be modularly connected to abase plate such that the pyramid section may be adjusted in XY positionon the base plate so that the desired femoral angle, weight line, andgeneral biomechanics of alignment may be realized for the particularuser. Connected to such base plate may be a mounting point 1604 forother prosthetic components. Alternatively, other attachment means maybe used, and should not be considered limiting. Such base plate may befabricated from metal, carbon fiber, or other such materials that may besufficiently strong enough to support the users weight and forces. Holesmay be placed in the material to modularly adjust the mounting positionsof the various components.

Pads:

As is generally illustrated in FIG. 17, in a preferred embodiment, suchforce bearing elements including but not limited to the struts,connector pieces, adjustable connector sections, gluteal span, orothers, may utilize padding on their inner side to provide a morecomfortable and gradual dispersion of forces about the limb.

In a preferred embodiment such pads may be modularly removable, in orderto modularly replace the pads. The pads may utilize any conventionalattachment means including but not limited to VELCRO, sticky material,fasteners, mechanical means, slots, or others.

Such pads may be available in various characteristics such as but notlimited to thickness, durometer, flexibility, combination of durometers,combination of flexibility in various areas, width, tapering, attachmentor suspension methods, with varying surface characteristics, materialselection, surface tension, surface friction, or other suchcharacteristics.

In such an embodiment, by way of example, a thicker or wider or stifferpad may be used for a patient with a considerable amount of soft tissue,whereas a thinner or narrower pad may be used with a patient who is moremuscular.

As may be generally illustrated in FIG. 18, in a preferred embodiment,the pads may utilize one or more durometers, or other characteristics asmentioned above. In such an example, a pad with more than one durometermay utilize areas of higher durometer 1801 and areas of lower durometers1802. Such areas may be uniform across the pad, as may be layered, ormay not be uniform across the pad. In such an example where there may betwo or more durometers for example, a higher durometer for instance maybe across the outer surface of the pad in order to increase durabilityagainst an external supporting member, and a softer area of the pad maybe on the inner surface to allow for comfort and conformability to theuser. In addition, other layers of various durometers or othercharacteristics may be used such as but not limited to, for example, yetanother area of slightly higher durometer on the inner side of the padto help disperse the forces more broadly by a middle softer section'scompression. Similarly, the pad may utilize surface coatings or othermaterials adhered to its surface to accomplish the same. By way ofexample, fabric, VELCRO, plastic, nanotechnology, gecky-inspiredtechnology, or other materials may be bonded or adhered to at least onceside of a pad in order to provide such varying characteristics of thepad assembly, including suspension capabilities. The pad may beconnected to a supporting or medial member by VELCRO or other commonlyused connector means 1803.

Likewise, external materials or pad materials may have varying degreesof surface tension, friction, or sticksion. Materials may be used thathave a high coefficient of friction against the underlying limb orliner, or it may have a low coefficient of friction to prevent tensionagainst the limb or liner. In a preferred embodiment it is contemplatedthat higher tension between the pad and the limb or liner is moreadvantageous to prevent the limb or liner from moving with respect tothe pad.

In another embodiment, VELCRO or the like may be applied to the innersurface of such pad, or supporting members, in order to increase thecoefficient of friction, or mechanical lock, to the underlying liner orthe like. By doing such, the limb may be mechanically held within thesocket by way of a mechanical lock. In conventional socket designs thiswould be a limiting factor as doffing the device would be challenging.However, within this disclosure, the design inherently provides a socketthat can be detached in such a way as to allow the user to effectivelydoff the device in a user friendly way.

As is illustrated in FIG. 19, there may additionally be variousstackable materials 1901 that may each be modularly connected ordisconnected. By way of example, various pads may be applied in seriesto allow for a change in thickness, or even tailoring of contouring byapplying additional inserts between such a supporting element and a pad,thereby changing the shape within such a system. Such an insert mayutilize hook and loop on its two sides respectively to simply be appliedbetween and attach to supporting structure 1902 and the pad, or may beconnected with any other known means.

In a preferred embodiment, and as one possible embodiment may generallybe illustrated in FIG. 20, such pads may utilize raised or depressedshapes across its surface, in order to help increase the surface tensionor mechanical lock between the pad and the limb or liner. Such shapesmay be formed in many different characteristics including thickness,width, geometric or non-geometric shapes, design, texture, or otherwise.

Such shapes may offer various orientations such that they may inherentlyprevent the limb or liner from shifting proximally or rotationally. Asis illustrated in FIG. 21, and by way of example, such shapes 2101 mayhave a general angulation such that the limb or liner is preventing fromslipping past them. Such shapes may compress in certain directions, butexpand in others. By doing so, the limb may be allowed to seat into thesocket, but may be prevented from pulling out of the socket.

Such pads may be fabricated from one or more of various types ofmaterials including but not limited to foams, silicones, rubbers,urethanes, plastics, textiles, mesh, fabric, or other such materialsutilized in the industry or for interface applications.

It should be understood that the term liner should not be consideredlimiting, and may generally refer to any number of materials that may beapplied over a limb, including but not limited to a gel liner, gel sock,fabric sock, sleeve, any combination thereof, or any other material orconfiguration that may be applied over a limb within a prosthetic ororthotic device.

In an alternative embodiment as shown in FIG. 22, such pads 2202 may beapplied within a conventional socket shape 2201 to help increaserotational stability and/or suspension. In such a case the existing orconventional socket may be, but not necessarily is required to be, splitin such a way as to be adjustable so that the socket may be tightened orloosened to accommodate for volume change, fit, or simplicity of donningand doffing such a system. In such a case, the insertion of such padsmay help lock the position of the bone of the limb into a certainorientation by virtue of compressing the soft tissue around it.

Such pads, materials, shapes, or surfaces may mate with opposing surfaceof a liner, in order to increase a lock of the socket to the liner/limb.If a liner or the like may be used on the residual limb within such asystem, such a liner may utilize a surface material that may inherentlymate with such shapes or surface structure of such a pad. Such materialor materials on the liner may amplify the effectiveness of a mechanicallock or other bonding methods with the pads.

In order to increase the surface bearing area of the interface about thelimb, while maintaining a compliant interface, in a preferredembodiment, the vertical and/or horizontal connection section pads mayutilize a connection means to an underlying compliant member that may bedonned over the limb, such as a liner/sock. By way of example, a gelliner may be donned over the patient's residual limb. Such gel liner mayutilize a surface covering that may have surface tension or otherconnectivity means to the interfaces connection sections (such interfaceconnection sections may include any number of vertical struts,horizontal connection members, or other such sections). In a preferredembodiment, such surface to surface connectivity may utilize hook andloop VELCRO or the like. In a preferred embodiment, utilizing such aconnection across and around a proximal band of the interface, or anyarea of such vertical interface sections, or any combination thereof orother, may allow for the remainder of the limb to suspend in ahammock-like manner within its gel liner, as is illustrated in FIG. 23with VELCRO patches 2301 placed along supporting members to connect aliner for instance to the socket. It is contemplated that a similareffect may be achieved with a fabric sock, donning sleeve, shrinker, orother such compliant members which may fit snug over the residual limb.It is also contemplated that such hook and loop may connect suchinterface to an underlying member along such vertical strutsections—which may include 1, 2, 3, or 4 of such vertical members, withor without combination with any number of horizontal connection membersas well.

In such an example, the liner or sock element may have a certain amountof elongation potential as such material may be stretchy, or may haveinherent compliance. Such underlying limb may generally be supported bysuch material, and such connectivity of such material to an externalsupporting structure may generally result in a hammock-type effect,whereas the liner or sock material may act as a hammock, the supportingstructure (such as sections of the struts of a socket) may resemble ahammock-stand, and the limb may resemble a person laying in a hammock.In such an example, as a person may lay in a hammock, their entire bodyweight is supported by the hammock itself, which is supported by thehammock stand. In such an example, the person's full body weight isdistributed over a broad surface area and such hammock is conforming tothe shape of such body, resulting in a comfortable interface. In theprosthetics equivalent example, the liner or sock may generally supportthe users weight, as well as biomechanical lock about underlyinganatomy. The liner or sock may help prevent expansion of the tissue inelongation, circumferential expansion, or other, or any combinationthereof. Additional elements may be applied to the liner or sock tofurther help control and/or manage the tissue within the system. In oneexample, and as described in additional patent application by this sameinventor, a flower shaped connector may be applied over the distal endof a liner or sock, eliminating or reducing elongation orcircumferential expansion of the liner, and creating a form fittingsocket over the end of the limb. Likewise, it is contemplated thatnon-elongating hook VELCRO type strips, or other methods, may beconnected to a liner or sock which may be not have integratedanti-elongation strips, and such combination may be used to preventelongation of such liner or sock.

Alternatively, other methods may be utilized to quickly create aform-fitting socket about a residual limb such as impregnated at least aportion of a fabric sock or the like with a material in a general liquidform which may then hold its form upon changing it state. By way ofexample, materials such as silicon, urethane, or other similar materialsmay be used. Such materials may get impregnated into at least a portionof a fabric sock (or functionally similar article) that is donned over alimb, and which is then able to set off, providing a form fitting socketto a user. The sock may give compression to tissue and conforming aroundthe limb. The impregnated silicon for instance becomes the structureelement, and setting off in the socket gives the shape.

Ladder Strap with Numbers:

In a preferred embodiment, a connector means may be used which may offerdocumentable increments of tightness. In one such embodiment, a ratchetand ladder strap may be used which may offer numbered or use otherincrements which may be used to alert the user or practitioner how tightsuch a connector piece is. In a preferred embodiment, such a ladderstrap may utilize numbers listed on various ladder increments. Suchnumbers may be listed in order, and such numbers may begin at themountable end of the ladder, such that the open end of the ladder may becut to length, and allow the remaining numbers to remain in orderstarting with the lowest and working upward as it extends to the cut endof the ladder strap.

Such numbers may be listed on each ladder section, or may be listed byincrements of two's, five's, ten's, or other. Such numbers may as wellbe linear along the strap, or may be offset at angles to enable the userto better read the position, without having to fully read the actualindividual number. In such a case, the numbers of increments of fivesmay be on the far left side for example, and the following numbers maystair-step in position across the ladder. The same may be accomplishedin sets of 10's. It is contemplated that only the fives or tens may belisted on the ladder strap, and the remaining rungs in between may nothave numbers listed.

FIG. 24 generally illustrates one embodiment of such ladder strap withnumbers along the rungs of the ladder.

Likewise, cross connector pieces may be used with numbers as well toalert the practitioner of the position of such connector between suchinterface sections.

FIG. 25 generally shows an embodiment of a cross connector strap withnumbered holes. The hole at least one end of such connector may beoffset by a certain amount to increase the number of possible positionsof such a strap. For instance, if each hole is ½″ apart, the holenumbered 0 may be offset by ¼″ from the other holes, such that theentire strap may have ¼″ increments with larger hole spacing, providinga more durable strap.

Components and Fit:

In a preferred embodiment, modular components may be used to alter theposition and angulation of at least one, and preferably two, verticalsupporting members.

Such supporting members 2601 may be fabricated from thermoformable ornon-thermoformable materials. In a preferred embodiment, thermoformablematerials may be advantageous to contour such members to the underlyinganatomy, especially on the proximal end. It has been found that it isnot necessary to contour any supporting member (or medial verticalmember for that matter) at all and maintain full functionality andcomfort. Thermoformable members may be made of thermoformable carbonfiber, injection molded plastics, or other materials. In a preferredembodiment, such members may be fabricated from injection moldedplastics. Such injection molded materials may utilize nanotechnology toincrease their strength and rigidity.

Such vertical supporting members in a preferred embodiment may generallybe positioned along the lateral and/or anterior lateral aspect of atransfemoral limb for instance. One supporting member may generally bepositioned between the hamstrings and the lateral aspect of thequadriceps, and generally run from posterior to the distal aspect of theresidual bone to the pocket hollow area, just posterior to the proximalaspect of the residual bone. A second supporting member if used may runfrom anterior to the distal end of the residual bone to anterior oranterior/lateral aspect of the proximal end of the residual bone. Bypositioning such supporting members like this, the distal end of theresidual bone may generally be positioned to float there between,leaving no structure in which the sensitive end of the bone may hitagainst.

Between the supporting members, toward the distal end, but proximal tothe distal end of the residual bone, a compliant bridge 1708 may spanthere between, allowing for a pad to be placed to post the bone, andcontrol its position and movement.

In such a system it is contemplated that the distal end of the residuallimb may not need to be in direct contact with the distal end of asocket, and instead may generally float with no contact with any rigidor semi-rigid structure. Instead, the use of a sock or liner may be usedas a “hammock” to support, manage, or control underlying tissue withinthe system, and functionally act like a conventional rigid socket mayact about the limb.

It has been shown in conventional socket designs that encapsulate thelimb, that a lack of distal contact with the end of the socket mayresult in circulatory issues of that tissue, and is generallycontraindicated. However, since this socket design does not encapsulatethe entire limb, and since the hammock effect is utilized to control andmanage the tissue, having lack of contact about various aspects of thelimb including the distal end is found to be more comfortable bywearers. The underlying limb and tissue may be supported by a complianthammock instead of being supported by a rigid socket.

The proximal end of at least one of the supporting members may beconnected to a compliant band or swing strap 1704 (FIG. 17) that mayspan around the medial aspect of the limb and back to the othersupporting member, or itself. By way of example, such compliant band mayspan from the lateral posterior supporting member around the glutealarea, under the medial aspect of the groin, around the anterior aspectof the limb, and connect back to the lateral anterior supporting member.In such an example, such compliant band may functional similar to how aclimbing harness may function in supporting the body.

The term compliant band should not be considered limiting and mayencompass webbing, fabric, plastics, foams, laminates, or any othermaterial. Such band may additional include areas that are more compliantand areas that are less compliant, and may even have rigid areas within.In a preferred embodiment, the compliant band may be fabricated fromfabric webbing material such as nylon webbing for at least part of itsspan. Such compliant band may utilize means for attaching a pad acrossit, such as a foam pad, and such means of attachment may utilize VELCROor other attachment means. It is understood that such compliant band maynot be in one piece, but may include various pieces to make up suchband. Other sections of such band may include a length adjustabilitymeans, such as but not limited to a ladder strap which may engage in aratchet mechanism.

Any such ladder strap or cross connector sections may utilize aconnectivity means across their back side, such as but not limited toVELCRO for example, which may then attach to a pad to help distributethe forces over a broader surface area.

Through using a section of the band which may be disconnected, such as aladder strap and ratchet mechanism, such socket design may be disjoined,allowing it to be opened up. By way of example, a limb shape isgenerally round. Socket shapes are therefore typically generally roundto match the underlying limb shape. By opening up the socket, the socketmay be splayed open, and may generally lay flat. This may allow the userto more effectively or easily donn such a device.

Such band may as well connect to other members. For example, a generalmedial vertical structural member may be connected to the band near thetuberosity area and generally run distally from there. Another medialvertical structural member may be connected to the band near theanterior aspect of the adductor longus tendon and generally run distallyfrom there. Such medial vertical members may be connected together, aswell as connected to the lateral supporting members at some more distallevel. The medial vertical members may help prevent the proximal bandfrom digging into or roping into the limb, by spreading the forces downthe length of the limb by virtue of its connectivity. In addition, thiscompilation helps to control and manage the underlying bone moreeffectively.

In fabricating a conventional socket, great care is taken to customtailor the shape of the socket shape for the user. The socket istypically hand sculpted to match the underlying anatomy, such as aroundthe adductor longus tendon, around the ramus, at the distal end toprovide space for the distal cut end of the bone, and around the musclebellys and soft tissue. Since the human body is so dynamic, the customtailored socket will likely no longer fit appropriately with just asmall change in body weight. When a practitioner needs to makeincremental changes to the shape or contouring of a socket, during thefabrication and fitting processes, they will likely use a heat gun tomodify the thermoplastic socket, or grind part of the material away ofthe socket, or place pads within the socket. Each of these adjustmentsis time consuming, is inexact, and is not simple or often not possibleto reverse.

Similarly, long ago the alignment of a prosthetic was equally as inexactand challenging, by requiring the socket to be cut off from theunderlying components, repositioned, and bonded back on in order to makeeven small alignment changes.

In years past endoskeletal components were introduced to the prostheticsfield, which use a male pyramid and female receiver to provideincremental, simple, and reversible adjustments to the alignment. Thisaddition revolutionized the fitting process of a prosthetic, as evenminor modifications could be done to the alignment in real-time. Thosechanges could be reversed. And those changes could be quantified, anddocumented.

In a similar way, the prosthetics field needs a method of documentingand quantifying the prosthetic socket fit. There is also a need to allowa practitioner to be able to simply, quickly, and easily modify the fitin each of the areas of interest in real-time, to test how a change mayfeel to the user, and be able to just as easily reverse that change.Current prosthetic fitting approaches do not allow for that to takeplace.

This disclosure allows for just that to happen. Through the use of thevarious cross connectors, adjustment mechanisms, and swing strap, everyaspect of the fit of a prosthetic can now be adjusted in real-time—allof which are quantifiable, documentable, and reversible. Such crossconnectors, swing strap, and adjustment mechanisms may be flexible,compliant, soft, or otherwise conform for the user with varying degreesof flexibility.

The cross connectors in this design may utilize incremental adjustmentmeans to alter the distance between their connection points. In oneembodiment, this may be holes in a strap, though this should not beconsidered limiting, as there are numerous embodiments that couldaccomplish the same.

Beginning with FIG. 17, the proximal medial connector 1702 connects thetwo medial floating members 1703. Each floating and anchor member mayutilize methods of attaching cross connectors, such as incremental holesto provide anchor points, although other attachment methods arecontemplated, and should not be considered limiting. As this section istightened, it allows for the proximal medial swing strap 1704 to havemore space, and hence can have additional room for the adductor longustendon and related anatomy. In typical sockets, the socket shape iscontoured around the anatomy as such, and the contouring of thisdisclosure can highly resemble a conventional socket contouring, bymaking this incremental change to the tightness of the cross connector.

Cross connector 1705 on the medial distal aspect of the socket may beused to adjust the angle and span of the two floating medial members.This may impact the available circumferential positioning of the medialmembers as well as the relative and available positioning for the anchormembers.

The proximal posterior cross connector 1706 may influence the amount andshape of contouring of the swing strap. It may also influence the amountof suspension of the swing strap to support the users, as well as therelative positioning of the posterior medial floating to the tuberosityarea. The distal posterior cross connect also may have influence on thecircumferential positioning of the medial members as well as therelative and available positioning for the anchor members.

Lateral proximal cross connector 1707 may provide added system rigidityby preventing the anchor members from splaying apart under load.

Distal lateral cross connector 1708 may be positioned proximal to thecut end of the bone, such that a pad may be placed between it and theuser if chosen, and may post the bone. By doing such, it may control theposition of the bone within the socket, and provide increased bonecontrol and comfort for the user.

Anterior connectors 1709 may be adjustable, and removable, such asladder and ratchet straps. In such an example, incremental adjustmentsto the circumferential tightness of the system can be accomplished.

Each of the cross connectors, and ladder, may use markings to showrelative positioning, such as numbering their ladder rungs, or holeswithin the cross connectors, or other means, so that a practitioner oruser can compare and quantify relative positions, and document suchpositions. With so many adjustment means within the system, apractitioner can custom tailor an entire socket, in each and every areawhich a socket needs to be tailored, but in a quantifiable,documentable, and quickly and easily reversible manner. This allows apractitioner to test various fitting changes in real-time.

If padding is needed, pads may be applied between any such crossconnectors or ladders and the user. Such pads may be attached in anynumber of methods known in the industry, including VELCRO or bondingthem.

In addition, the swing strap 1704 may be attached to its ends in such away as to allow for incremental adjustability to adjust tightness andsuspension. Such swing strap may be fabricated out of any number ofmaterials, but in a preferred embodiment, it may be fabricated fromnylon webbing or the like, which is very durable, very lightweight, andvery flexible. Such swing strap may incorporate a means for connecting apad, such as VELCRO. Such pad may be connected to the swing strap, andprovide added cushioning and comfort to the user, as well as to controland manage tissue. Any such pads within such a system may be removablefor washing, replacement, or adjustments, such as skiving the pad to adifferent shape to accommodate for contouring of the limb or comfort.

Such swing assembly may be connected to the lateral anchor members ontheir proximal ends. In one embodiment, the posterior aspect of theswing assembly may connect to the posterior lateral anchor member, andthe other end of the swing strap may connect to the anterior medialfloating member. That anterior medial floating member may then have anadjustable strap connected from it to the anterior lateral anchormember, providing a complete connection around the medial aspect of thelimb, to both anchor members. By doing such, the proximal brim may actmore like a swing or hammock, and the anchor members may act like ahammock stand.

A floating member may utilize a more flexible member 1710 attached to iton the user side of the member, such that the proximal end of suchfloating member may have gradual tapering of relative stiffness,preventing it from digging into the user on its proximal edge.

In such configuration of the swing strap and flexible members, theentire proximal brim may be flexible and compliant, lacking rigid orhard elements as are found in conventional prosthetics. Conventionalprosthetics all use a rigid shelf to seat area to sit onto near theirtuberosity area, which is uncomfortable for the user. In this disclosurehowever, such proximal brim may be entirely compliant, allowing forthere to be no hard shelf, but rather a brim shape that more resembles ahammock or swing instead.

Toward the distal of the medial floating members, at least one of suchmembers may be modularly connected to the main base, such as themounting point where the knee may attach. This may be accomplished by adynamic tab which may allow for infinite 360-degree rotation at itsattachment to provide optimal positioning about the limb. Such dynamictab may allow for another connector piece to be attached, such as butnot limited to a ladder strap. Such ladder strap for example, may thenconnect to a ratchet which may be mounted on a medial floating member.Connecting the two together with a compliant strap such as this allowsfor the medial floating members to be pulled distally, which inherentlytightens them against the limb as a 4-bar linkage operates. This mayhelp to solidify the structure of the socket as a whole, even thoughmany of the connectors may be quite compliant and flexible. This unitesthe socket and the limb into one functional element, providing a greaterone-to-one connection between the limb and the socket, and henceunderlying bone to socket.

It is contemplated that similar means may be used for other limb levels,such as transtibial limbs, and in such examples, the lateral aspect ofthe limb may not be the preferred positioning, as it would be for atransfemoral use-case. Such positioning may be custom tailored to theprosthetic level, and more specifically to the users' requirements. Inaddition, it is contemplated that the supporting members for atransfemoral design may as well be positioned in positions other thanjust the lateral posterior and lateral anterior aspects of the limb.

The use of any flexible contoured “socket” about the limb may besupported by such a system. If such underlying socket were fabricatedfrom conventional or similar materials, the modularity of this systemmay allow for an end user to self-adjust the socket. Conventionalfittings typically use a custom fabricated inner socket shape to theuser. This disclosure certainly could become the frame around such innersocket shape, allowing for the benefits of using a conventional innersocket if the practitioner should choose to use such a device, and takeadvantage of the adjustability and simplicity of fitting this designaround it.

To fit such a system to a user, the use of modular components may beutilized to fine tune the position of supporting members about the limb.In general, each supporting member(s) 2601 (and by example, one on thelateral posterior aspect of the residual bone, and one on the lateralanterior aspect of the residual bone) may be connected to an adaptor2602 which may connect it to a modularly adjustable component. By way ofexample, such adaptor may be in the form of a through-hole tube clamptype of adaptor. Such adaptor may connect to the supporting member, andmay connect to a pylon 2603, although other embodiments, and even moresimple embodiments, are certainly contemplated, and such example shouldnot be considered limiting.

This configuration may allow for such vertical supporting member to beadjusted in position up and down with respect to the body, as welladjusted in rotation so that it may lay flat against the body.

Such tube or pylon which connects proximally to the through-hole tubeclamp adaptor or the like, may then connect distally to a typical tubeclamp or female adaptor 2604, which may then engage with a male pyramid2605. Such intersection may allow for modular adjustability of theangulations of the vertical supporting member(s).

Such male pyramid may be connected to a horizontal plate 2607. Suchplate may have various possible positions in which the male pyramid maybe mountable, in order to alter the lateral positioning of thesupporting member with respect to the limb. This may help accommodatefor various size limbs.

As illustrated in FIG. 27, such horizontal plates may be connectedtogether with through hole bolts, which may connect to a four-hole plateon the inside of the device, and may connect to a four-hole male orfemale pyramid on its distal aspect, which may be then be connected to aknee or other components.

If more than one horizontal plate may be used, it may utilize adjustablemeans to modularly adjust the position of one plate with respect to theother. Through such a slot configuration as is show in theillustrations, 360 degrees of adjustability may be realized for eachplate. It is contemplated that 1, 2, 3, or 4, or more plates may beutilized within such a system. Such plates may be marked to quantifytheir relative positions.

Such components may be used for in-office fittings, to allow apractitioner to set the position of the supporting struts to the user,and establish general alignment of all aspects of the device. They mayalso be used for definitive use as needed.

Various methods of connectivity for any such components arecontemplated, and those described should not be considered limiting.

When transferring from the fitting components to a definitive setup, thefitting components may be placed in a typical transfer jig in order tocapture the alignment and position of the supporting struts with respectto the underlying component such as the knee and foot. The struts may beswapped for dummy struts, which may be used for laminating a distalsocket, and replacing with the actual struts after the lamination, orthe like, is fabricated.

Alternatively, a modular adjustor mechanism may be used to connect thesupporting members to the distal end. While there are variousembodiments that may be utilized to connect the supporting struts towhere the knee or distal components connect, the example of a preferredembodiment as described below captures various preferred characteristicsof such a system, including simple modularity, cost effective, and lowprofile design.

In a preferred embodiment, such components may allow for infiniteadjustability to custom tailor the connectivity position to the user, sothat a select few components may be used for many differentconfigurations. Simultaneously, such components should be able to remainvery low profile and contoured about the residual limb whereas to notresult in a bulky socket.

In one embodiment, as generally illustrated in FIG. 28, such distalattachment plate may be formable, such as but not limited tothermoformable, so that after use of it with the other fittingcomponents to establish proper alignment and positions, in a transfer,its lateral end could be heated, for example, and bent into position,creating a bent structural supporting member to connect the kneeattachment area to the strut.

Alternatively, such distal attachment plate may be cut to length, and asecondary curved member may be attached, which may or may not bethermoformable, to allow for connection between the distal end kneeattachment area to the supporting members.

Any such component of the fitting system may utilize branding on it,including the proximal four-hole attachment plate.

Transhumeral Socket

In a similar method as described for transfemoral applications, asimilar set of components may be used to fit other levels ofamputations. For example, in a transhumeral fitting, a supporting membermay be used which generally may have a distal attachment plate to mountto components such as a prosthetic elbow. Such plate may be near 90degrees to the long section of such member, which may generally runalong the length of the residual limb, toward the axilla, though may belocated on either side of the limb. Attached to at least one supportingmember may be at least one floating members. Such floating members mayfunctionally act similar to the floating medial members of thetransfemoral use-case example as described previously. Such floatingmembers may generally reside on the medial aspect of the arm, and/or mayreside just lateral to the biceps and/or in between the two heads of thetriceps. All three (for example) members may be joined with compliantconnectors. Such compliant members may be similar to those of thetransfemoral fitting level, although their characteristics may beslightly modified such as in flexibility, method of adjustability, orwidth, or others. Disconnectable adjustors may be utilized to allow thesystem to splay open. Such adjustors or connectors may be able to beadjusted in position or tightness, allowing the user to self-tightentheir fit. Such connectors may encircle the limb, connecting allfloating and supporting members together around a limb. Each of suchmembers may have means for connecting a pad within, and may additionallyutilize connectivity means to an underlying liner or sock, as describedin the transfemoral section, including, but not limited to VELCRO.

Similar to the dynamic tab as described in the transfemoral socketexample, the floating members may be connected to either the distal endof the main support member to provide the 4-bar linkage effect to lockthe socket about the body more effectively. Alternatively, the floatingmembers may be connected to the harness, such as vest harness(MartinBionics) design, and such connectivity force may accomplish thesame. Or a combination of the two may be used.

For upper extremity users, the use of a sock or liner to control andmanage the residual limb tissue can still be quite valuable, and can beused to further distribute the forces over a broader surface area, andprovide suspension capabilities. Using VELCRO, for instance, to connecta liner to the pads of the floating or support members can be aneffective way to achieve suspension.

Similar to that described in the transfemoral level fitting, crossconnectors, adjustable connectors, and other such elements may beincorporated within, to allow for quick and easy modular adjustabilityof the fit in every area of the socket where a practitioner maytypically fit the prosthetic to the user through conventional tailoringmethods.

The proximal medial aspect of the socket may utilize a floating brimdesign, and in a preferred embodiment may be made of comfortablematerials such as fabric and/or foam, by way of example. Other materialsmay be used as well. Such floating brim may be connected to anchoredand/or floating struts, and may be adjustable in length. Such floatingbrim may provide accommodation to the dynamic nature of the axilla area,and provide additional comfort. Such brim may functionally be similar tothe medial brim of the transfemoral application socket.

FIGS. 29A-29E generally illustrate various embodiments of how such asocket may engage around a residual limb at the transhumeral level.Similar means may be used as described in the transfemoral level, thoughspecific to the anatomy of this limb segment.

Transradial Socket

Likewise, a similar method may be used to connect such a device for atransradial limb. In such an example, at least one supporting member maybe applied along the anterior or posterior aspect of the lower arm(front or back of forearm), as in the position on an anatomical chart.Such floating member(s) may run along opposing sides of the arm. Allsuch members may be connected together with compliant connectors, and atleast some of such connectors may be quickly and easily adjustable, andmay be able to be splayed open, versus remaining as a socket, which bydefinition is a natural or artificial hollow into which something fits.It is contemplated that other configurations may be utilized toaccomplish the same.

The use of such an open socket, versus a traditional encapsulatedsocket, inherently allows for the system to not trap as much heat, beconsiderably cooler, lighter, more breathable, and allow for simpler andmore effective connectivity of EMG controls or other such sensors.

Similar to the transfemoral use-case example, the proximal anterior(front side of arm in the anatomical position) aspect of the socket mayutilize a floating brim, which may be made of comfortable materials suchas but not limited to fabric, webbing, foam padding, or others. As theelbow may flex, the comfortable materials may match to the underlyingdynamic body, providing additional comfort. Such brim may be connectedto floating member, anchor members, or a combination of both. It mayalso be adjustable, allowing the socket to be tightened to userpreference.

Through allowing a supporting member to be attached to floatingmember(s) provides an opportunity that conventional socket designscannot. For instance, VELCRO, or other textured materials, would beimpractical for an amputee to use in a conventional socket forsuspension, as there would not be a way of releasing it since a hollowsocket cannot open up. But since this/these designs can be splayed openthrough the use of the floating struts, such a system can utilizeVELCRO, or other such connectivity means, and the user can still doffthe device when needed with ease, yet have incredible suspensioncapabilities when the socket is donned.

For any such fitting level application, a conventional socket, or aportion of a conventional socket may be attached within the system toutilize benefits of conventional socket fitting or suspension methodswithin such a system. Such a socket may be connected to the supportingmembers, the floating members, or a combination of both. Likewise, itmay not be connected to either, and only be connected to the distal end.

FIGS. 30A-30E generally illustrate various embodiments of how such asocket may engage around a residual limb at the transradial level.Similar means may be used as described in the transfemoral level, thoughspecific to the anatomy of this limb segment.

Transtibial Application

Transtibial use-cases may be highly similar to the transfemoralapplication in many ways, though with slightly different configurationsof similar components. For a transtibial application, supportingmember(s) may be used on the anterior, lateral, medial, and/or posteriorsides, although in a preferred embodiment they may be located at leaston the anterior side. There may be at least one such supporting member,and in a preferred embodiment perhaps two.

In one embodiment, a supporting member may run along the anteriorlateral aspect of the tibia bone, while another supporting member mayrun along the medial aspect of the tibia bone. Floating member(s) may beused along the posterior aspect of the limb, such as up the middle orsides of the gastrocs muscle belly.

Alternatively, supporting member(s) may be used along just the medialaspect of the tibia for instance, with floating members along theanterior lateral aspect of the tibia, and/or along the posterior aspectof the limb.

Alternatively, a supporting member may run along the posterior aspect ofthe limb, with floating members along the anterior lateral and anteriormedial aspects of the tibia.

In any such configuration, similar connector means and self-tighteningmeans may be used to connect supporting and floating members togetheraround such a limb, as has been described in the transfemoralconfiguration example. In addition, such system may also utilize pads,dynamic tabs, and other such components of a transfemoral system, butconfigured specifically to the transtibial level.

Spanning within and between such anchor and floating members may bevarious configurations of pads, which may be used to contain and controltissue management within such a socket. Such pads may or may not beconnected together distally.

At the distal end of the socket may be an attachment point for modularcomponents such as pylons or feet, as would be typically found in suchapplications.

In one embodiment, the posterior proximal aspect of the socket mayutilize a floating brim, which may be made of conformable materials suchas but not limited to fabric, webbing, foam, or others, by way ofexample.

Further, since such a socket may be able to splay open, it mayaccommodate for volumetric change by tightening up or loosening thecircumferential dimension of the socket, by way of adjustability meansas illustrated in the figures.

Any such sockets may utilize areas of custom molded contouring about thelimb shape, in additional to purely modular areas of conformity. Forinstance, custom molded areas around the tibial and femoral condyles maybe accomplished through custom molded areas as in conventional fittingmethods, which may attach to the modular areas, or such area may utilizeoff-the-shelf section that may then be customized to fit the user.

FIGS. 31A-FIGS. 31G generally illustrate various embodiments of how sucha socket may engage around a residual limb at the transtibial level.Similar means may be used as described in the transfemoral level, thoughspecific to the anatomy of this limb segment.

Liner Suspension

In conventional prosthetics, gel liners are used to provide cushioningfor amputees, within rigid sockets. With this disclosure, there may notbe a rigid socket, and hence the requirements for and advantages of agel liner may be distinctly different. In conventional sockets, there isvacuum that is created between a liner and an encapsulated socket tohelp hold the prosthetic in place. A seal is formed between the limb andsocket or liner and socket to achieve such suspension. In thisdisclosure, a gel liner or air impervious liner may be used to suspendthe prosthetic, by attaching it directly to the prosthetic withmechanical means, or other. For instance, and by way of example, a gelliner with loop VELCRO on its outer covering may be mechanicallyconnected to VELCRO hook which may reside on the inner surface of anchoror floating members of this disclosure. Because this disclosure offers adevice that can be effectively unwrapped from around a limb, versus atraditional bucket socket, the VELCRO may be used to mechanicallyconnect such VELCROs together, maintaining suspension. Because the gelliner may not allow air to enter, it may effectively be held onto thelimb with suction, negative pressure, or vacuum.

Attaching a liner in removable manner, as generally illustrated in FIG.32, to a strut type of design directly, for suspension, is unique foruse in prosthetics, as no other strut type of designs used inprosthetics utilize a removable connectivity between the two forsuspension.

Swing Brim

Users of conventional prosthetic sockets often experience discomfort inareas such as the proximal brim, such as the ischial tuberosity, ramus,and general proximal medial, anterior, and posterior aspects of aconventional socket. In such conventional sockets, the dynamic limb isencapsulated within a static socket shape, which results in rubbing,chafing, and pressure in these unwanted areas.

It has been discovered through the use of compliant brim designs, suchas those disclosed in this application and its priority applications,that the user can remain significantly more comfortable if the brimmaterials can conform to the user, versus the user having to conform tothe brim. As such, the incorporation of the disclosed brim design withina conventional prosthetic socket can significantly increase the comfortof the conventional socket.

To accomplish such, various fabrication integration options may be used,and those described below should not be considered limiting, but ratherare for examples of various options. It is understood that various otheroptions, including various trim line options and attachment options maybe used.

In a preferred embodiment, the swing webbing may incorporate contouringsuch that it may assist in laying at the correct angle and orientationaround the underlying anatomy as it wraps around the limb. In one suchexample, an illustration can be found in FIG. 33 showing one suchconfiguration. In a preferred embodiment, one side of such webbingmaterial may be VELCRO compatible, or other attachment methods, allowingfor padding to be attached to it, which may help further spread forcesand add comfort.

The ends of such swing webbing may attach to the frame or struts withconventional attachment means, which may include, buckles, rivets,screws, sewn in place, or the like. Such attachment means may beadjustable or non-adjustable as the practitioner deems necessary orpreferable.

Option 1 as illustrated in FIGS. 34A (lateral view), 34B (posteriorview), 34C (medial view), and 34D (anterior view): Conventional flexibleinner socket with Socket-less Socket Swing Webbing and frame. Innersocket may or may not be trimmed down.

A conventional flexible inner socket may be removed from a conventionalframe, and replaced with a Socket-less Socket frame structure around theconventional inner socket. Doing so may eliminate the rigid ischialseat, as it would be replaced by the swing webbing which may generallyspan from around the lateral posterior strut, connect to the posteriormedial strut, and span anterior toward the anterior medial strut andanterior lateral strut, forming a swing shape, with the two lateralstruts as the hammock stand.

Since the medial struts may generally float with respect to the distalmounting method, and hence not have a rigid structure underneath, themedial brim of the socket may generally offer greater compliance, andmore comfort. The socket-less socket frame around a conventional innersocket may also offer greater adjustability, by allowing for ratchet orsimilar adjustment means to tighten the span between various struts,causing the flexible inner socket to become tighter around the limb.

This may also expedite the fitting and fabrication process overconventional means, as well as create a more modular fitting method.

If the flexible inner socket is trimmed down from its original shape,the advantage of the swing webbing with integrated padding may be usedto replace a portion of the brim of the conventional socket. Forinstance, the posterior and medial aspects of the conventional brim aretypically uncomfortable in sitting and standing. Trimming these areaslower, and replacing them with padding over the compliant swing webbingmay allow for greater conformity and comfort.

Specific areas that stand to benefit from adjustments include:

Posterior brim: This area is often bulky in sitting on a chair, anduncomfortable in sitting. Lowering this area and replacing it withwebbing provides a lower profile build height, and hence more comfort.

Medial brim: This area is especially uncomfortable in conventionalsockets, as the medial brim typically uses a rigid ischial seat, andstatic ramus shape. Much of the discomfort experienced in conventionalsockets is in this area. Replacing the brim with conforming webbingmaterial for instance, allows it to conform to the user, versus the userconforming to the static brim shape.

Anterior brim: This area is often uncomfortable in sitting, as itpresses into the abdomen during hip flexion. In conventional sockets,this area posts off the abdomen, and can cause a loss of suction insitting activities. By replacing this area with flexible conformingfabrics as a brim material, it no longer posts against the abdomen,allowing for better retention of suspension and comfort.

If the conventional inner socket is trimmed down, it may be trimmed inany or all of the above mentioned areas, including as well the lateralside. This may functionally allow for the inner socket to function muchlike a traditional socket-less socket fitting, but utilize and existingflexible inner socket. If the conventional inner socket remains intactin part or in its entirety, the comfort may still be greater byeliminating a rigid ischial seat, and allowing the brim in general tohave more conformity than a conventional frame surrounding it.

While there may be more conformity, the swing brim may simultaneouslycapture and control the tissue, and prevent ballooning of the tissue inthis area, as well as cold creep of the plastic, since it will besupporting the underlying flexible inner socket with a non-stretchmaterial.

Option 2 as illustrated in FIGS. 35A (lateral view of conventional innersocket trimlines compared to Swing Brim trimlines), 35B (posterior viewof conventional inner socket trimlines compared to Swing Brimtrimlines), 35C (medial view of conventional inner socket trimlinescompared to Swing Brim trimlines), 35D (anterior view of conventionalinner socket trimlines compared to Swing Brim trimlines), 36A (lateralview of conventional frame trimlines compared to Swing Brim usetrimlines), 36B (posterior view of conventional frame trimlines comparedto Swing Brim use trimlines), 36C (medial view of conventional frametrimlines compared to Swing Brim use trimlines), 36D (anterior view ofconventional frame trimlines compared to Swing Brim use trimlines), and37A, 37B, 37C, and 37D of integrated Swing Brim on a conventionalsocket: Conventional flexible inner socket and frame with modifiedtrimlines of both, to incorporate and replace the use of the a SwingBrim instead of static brim plastics.

Similar to option 1 above, remaining with a conventional socket ANDframe, both with modified trim lines, may allow the brim of the socketto benefit from a more comfortable compliant swing webbing, whilemaintaining a consistent fit within the remainder of the socket.

To accomplish such, the posterior, medial, and/or anterior brim of theconventional flexible inner socket and its surrounding frame can betrimmed down in various amounts as needed or desired, allowing the limband tissue to be encapsulated by the swing webbing and padding insteadof the conventional more rigid materials.

The swing webbing may be attached to the lateral posterior and lateralanterior frame areas, in similar positions as may be used with asocket-less socket frame configuration.

The contouring of the conventional flexible inner socket trim lines mayas well utilize areas to resemble the strutserts of a socket-less socketconfiguration. As such, the flexible inner socket may extend upward nearwhere the medial posterior and medial anterior struts may reside, andallow the swing webbing to attach to the flexible inner socket extensionareas. Likewise, between any of the various areas of the swing webbing,but preferably in the anterior section, the swing may be adjustable,allowing for the user to tighten or loosen the fit of the swing brim.

Referring to FIGS. 26A-26B, such fitting components may utilize a methodof determining the relational position of various fitting componentswith respect to others, including angles, positions, rotation, andheight amongst others. Such method of determining relative positions maybe used to determine the final alignment of the device, and used fordefinitive stage transferring. For instance, the position of thelaminating plate (or its equivalent) with respect to the two throughhold tube clamps which anchor to the two lateral struts may be used todetermine how the final assembly is fabricated. Knowing those positionswith respect to each other may enable one to fabricate a definitivelamination for instance, without having to have the specific componentsin hand, such as if a central fabrication facility may be doing thefabrication work.

In such an example, this may be accomplished through electronic means,with marks, or the like, on the fitting components to determine relativepositions, or other such means. In any example, the method shouldprovide a quantifiable determination of the angular, rotational,positional, or other orientation of the device.

Socket-soft

Using modular elements to assemble a socket about a user's limb allowsfor various configuration options to be quantifiable, recordable, andrepeatable. Specific elements of the modular assembly may further havenoted configuration options, such as but not limited to, numberingvarious holes or mounting locations.

FIG. 38 generally illustrates an embodiment of an illustration whichmounting holes in various sub-components may be defined in order toquantify a particular configuration.

By way of example, the fifth hole down from the top in the posteriorlateral strut may connect with the adjoining cross connector in its holenumber 0. All elements of an entire socket assembly configuration may bedefined with such a method. Additionally, there are general trends whichmay be relatively common amongst various fittings and configurations.One such example may be that the top hole in the posterior lateral strutmay generally connect with the swing webbing at that location. Trendsalso may occur when comparing limb size and shape with which connectionpoints intersect. For instance, a limb that is large in circumferencemay generally have a longer span between the various struts through thecross connectors. Likewise, a limb that is smaller in circumference maygenerally have a shorter span between the various struts through thecross connectors. Similar trends may occur with respect to limb lengthand mounting locations of the distal band of connectors.

Because of the inherent trends, an algorithm may be used to correlatethe defined configuration assembly to a limb circumference and/orlength. Through using mathematical modeling, correlation algorithms,look up tables, artificial intelligence programs, or common sense,amongst other possible methods, a user may be able to input limbmeasurements and create an output assembly configuration suitable forsuch a limb size and shape, without a need to directly fit the device tothe user to establish the same.

Such limb measurements may include, but not be limited to, proximalcircumference, distal circumference, limb length from one or more ofvarious relative distances along the limb, patient weight, scan of alimb, digitizing of a limb, tape measurements of a limb, or any otherphysical or electronic means of capturing limb size, shape, volume, softtissue and skeletal anatomy, or other parameters.

The output of such a method may be at least one of any commonly used toillustrate data, but may include methods such as an App, Software,computer generated output, computer generated illustration,illustration, picture, virtual reality, or know-how, amongst others. Inone embodiment, in the case of utilizing an App or Software, FIGS.39A-39C generally illustrate a possible work flow of how a user mayinput variables into such system, and result in an output.

Such as system may as well be used for: ordering a device in aparticular assembly configuration based on measurements, used forassembling a device in a particular configuration based on measurements,defining additional sub-components desired in a particularconfiguration, storing of user data or patient specific data,documentation of user data or patient specific data, trackingutilization of device, or other related information.

Upon actual assembly of such a device, based on measurements, an actualfitting on an end user may occur, and such a device may be furthercustomized to fit to the actual user.

Final fitting configurations, which may account for later fittingadjustments that may be made on an actual user, may be input to such asystem, and used for improving such algorithms. Self-learningalgorithms, modified algorithms, or other methods may be used tocontinue to refine the accuracy of the measurement-defined assemblyconfiguration to that of an actual fitting configuration on an actualend user.

Such a method may be used on any level of amputation, or fitting of anylevel or type of orthotic device through such a system.

In one embodiment illustrated in FIGS. 40A, 40B, and 40C, and similar toFIG. 1C, stabilizing unit 102 may generally be positioned near theadductor muscle group, and may generally contour over, in between, ornear the hamstrings and adductor muscle groups. Stabilizing unit 102Bmay generally be positioned on the lateral aspect of the limb, and morespecifically may be positioned along the posterior lateral aspect of thelimb, and more specifically may be positioned between the hamstrings andlateral quadriceps in some configurations.

The proximal brim may utilize a generally compliant member or structure200 to span between the stabilizing units 102 and 102B. The limb maygenerally be supported through these compliant members across the brimarea of the socket, including medially and posteriorly. The anteriorarea of the brim may also use compliant materials to span there between,and more particularly may use an adjustable member 4002A along with insuch area.

Between the two stabilizing units described, a floating member 4001 maybe integrated, which may be used to capture and control the limb withinthe socket configuration. For example, such floating member maygenerally be positioned to sit just anterior to the distal cut end ofthe bone. Likewise, at least one of the stabilizing unit members maygenerally be positioned just posterior to the cut end of the bone. Oralternatively, such anchored and floating members may generally bepositioned on either side of the such bone, whether anterior/posterior,posterior/anterior, medial/lateral, or other such combinations.

Through integrating such floating member 4001, and through adding anadjustability means or circumferential connector 4002B and or 4005, thefloating member may be user-adjusted to capture and control the limbwithin the socket interior 4006.

Such floating member may be relatively short, or may be long in length.It may be connected just to the other anchored stabilizing unit memberscircumferentially, or may also be connected to the brim area proximally,or may also be connected distally to other compliant members. In apreferred embodiment though, the floating member may not be connectedrigidly, but rather through “floating” it between rigid members throughcompliant materials may allow the floating member to be effectivelywrapped around the limb and contour to match the underlying limb shape.

Such floating member may be specifically contoured to match theunderlying anatomy, or may be a pre-determined shape. A pad may also beattached on its inside to allow it to press against the limb with morespecific contouring.

On the posterior/medial side of the system, another floating member 4003may be positioned generally near or in between the hamstrings andadductor muscle groups. Such floating member may also be connectedthrough compliant materials 4004 to other members such as the brim areaof compliant member or structure 200.

The floating members may use a material which generally can hold itsform, but may be relatively flexible or rigid in nature. As thecircumferential connectors 4005 and 4002B are tightened around the limb,the floating member may generally press against the underlying limb andhelp prevent the circumferential connectors from roping into the limbtissue.

In one embodiment, a compliant connector may provide a common mountingconnector for various stabilizing members and floating members,providing a visual ‘distal end’ to the socket. In such a configuration,the socket may offer a low profile cosmetic appearance about theunderlying limb, by effectively eliminating any potential socket bulkalong the anterior/lateral aspects of the socket. Through positioningthe anchored stabilizing unit members as positionally opposing eachother, the socket can also achieve a narrower medial/lateral dimension,thus more effectively capturing the underlying bony anatomy and providegreater control within the device.

The invention therefor contemplates a transfemoral level prostheticsocket apparatus for attaching a prosthetic to a limb of a usercomprising: a first stabilizer unit having a first proximal end and afirst distal end first end and adapted to be perpendicularly positionednear an adductor muscle group of said user; a second stabilizer unithaving a second proximal end and a second distal end and adapted to beperpendicularly positioned between a hamstring and a lateral quadricepsof said user; a proximal brim made of a complaint material spanning fromsaid first proximal end of said first stabilizer to said second proximalend of said second stabilizer and adapted to support said limb; a firstadjustable member having a length located opposite of said proximal brimand spanning from said first proximal end of said first stabilizer tosaid second proximal end of said second stabilizer wherein said lengthis adjustable; a floating member having a third proximal end and a thirddistal end perpendicularly positioned between said first stabilizer andsaid second stabilizer opposite and below said proximal brim and adaptedcapture and control said limb within said socket; and a secondadjustable member having a first end attached to said first stabilizer,a second end attached to said second stabilizer, and a length attachedto said floating member wherein said second adjustable member is adaptedto be adjustable in length.

It is further understood that the use of such a system has the potentialto functionally eliminate the need for expensive machinery commonly usedto fabricate conventional prosthetics, and reduce the toolset down tosimple hand tools such as allen wrenches for example. Furthermore, theuse of such a system has the potential to functionally eliminate theneed for a highly trained and skilled clinician to fit a prostheticsocket for instance, as much or all of a defined and successful fit maybe defined through an algorithm, or the like.

What is claimed is:
 1. A transfemoral level prosthetic socket apparatusfor attaching a prosthetic to a limb of a user comprising: a firststabilizer unit having a first proximal end and a first distal end firstend and adapted to be perpendicularly positioned near an adductor musclegroup of said user; a second stabilizer unit having a second proximalend and a second distal end and adapted to be perpendicularly positionedbetween a hamstring and a lateral quadriceps of said user; a proximalbrim made of a complaint material spanning from said first proximal endof said first stabilizer to said second proximal end of said secondstabilizer and adapted to support said limb; a first adjustable memberhaving a length located opposite of said proximal brim and spanning fromsaid first proximal end of said first stabilizer to said second proximalend of said second stabilizer wherein said length is adjustable; afloating member having a third proximal end and a third distal endperpendicularly positioned between said first stabilizer and said secondstabilizer opposite and below said proximal brim and adapted capture andcontrol said limb within said socket; and a second adjustable memberhaving a first end attached to said first stabilizer, a second endattached to said second stabilizer, and a length attached to saidfloating member wherein said second adjustable member is adapted to beadjustable in length.